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The combination of Immune Booster, Kumar Kalyan Ras, and Suvarna Basant Malti Ras in Planet Ayurveda’s ITP Care Pack is a powerful way to support your body’s recovery and overall vitality."

The addition of the immunotherapy drug atezolizumab to postoperative chemotherapy is not effective in patients with triple-negative breast cancer who are at high risk of developing metastases: The ALEXANDRA/IMpassion030 Randomized Clinical Trial

Sir, I have an oncology exam this week and your channel is saving me. It is the only one that talks about treatment in depth, but it is not a random conference talking about a specific drug. Thank you so much

"I’ve been dealing with ITP for months, but after starting Planet Ayurveda, I’ve felt a lot more energetic and healthy. Their products are helping me improve my blood count naturally!"

Are these results comcerning ? Current red blood cell smear 1+ anistocytosis 1+ ovalocytes And echinocytes. With biliruben of 4.1mg/dL and haptoglobin of 25mg/dL. I am having genetic testing but i am not sure what to do.

FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer - On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. Efficacy was evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial in 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients were randomized 1:1 to receive ensartinib or crizotinib. The main efficacy outcome measure was progression-free survival (PFS) as evaluated by blinded independent central review. The key secondary efficacy outcome measure was overall survival (OS). Ensartinib demonstrated a statistically significant PFS improvement compared to crizotinib with a hazard ratio (HR) of 0.56 (95% CI: 0.40, 0.79; p-value 0.0007). The median PFS was 25.8 months (95% CI: 21.8, not estimable) in the ensartinib arm and 12.7 months (95% CI: 9.2, 16.6) in the crizotinib arm. There was no statistically significant difference in OS (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570). The most common adverse reactions (≥20%) were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue. Recommended Dose The recommended ensartinib dose is 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Newly approved targeted therapy: zenocutizumab, a neuregulin 1 (NRG1) inhibitor - The US Food and Drug Administration (FDA) has granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus) as an intravenous infusion for the treatment of certain adults with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma.

Newly approved targeted therapy: zenocutizumab, a neuregulin 1 (NRG1) inhibitor - The US Food and Drug Administration (FDA) has granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus) as an intravenous infusion for the treatment of certain adults with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma. Specifically, the systemic agent was approved for those with advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion who progress on or after prior systemic therapy, according to the FDA. The approval was based on findings from the multicenter, open label eNRGy study. In the multicohort study, treatment was associated with an overall response rate of 33% among the 64 patients with NSCLC and 40% among the 30 patients with pancreatic adenocarcinoma, respectively. Median duration of response was 7.4 months in the NSCLC patients and ranged from 3.7 to 16.6 months in those with pancreatic adenocarcinoma.

My hb is 15.5,rbcs 5.12 hct 48.6 early my hb was 16.8 after phlebotomy it is 15.5 is it normal or i do further investigation

The US Food and Drug Administration (FDA) has approved Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adults with metastatic colorectal cancer (CRC) who have KRAS G12C mutations, as determined by an FDA-approved test, and have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The approval was based on data from the phase 3 CodeBreaK300 trial. The trial (NCT05198934) included 160 adults with KRAS G12C-mutant metastatic CRC who had received at least 1 prior line of therapy, including fluoropyrimidine, oxaliplatin, and irinotecan in the metastatic setting. The patients were randomly assigned 1:1:1 to receive sotorasib at 960 mg daily plus panitumumab at 6 mg/kg every 2 weeks, sotorasib at 240 mg daily plus panitumumab at 6 mg/kg every 2 weeks, or investigator’s choice of standard of care (SOC) trifluridine/tipiracil or regorafenib. The study’s primary endpoint was progression-free survival (PFS) by blinded independent central review. Panitumumab plus sotorasib at 960 mg improved PFS over SOC, but patients in the 240 mg sotorasib arm did not have an improvement in PFS over patients in the SOC arm. The median PFS was 5.6 months in patients who received panitumumab plus sotorasib at 960 mg and 2 months in the SOC arm (hazard ratio [HR], 0.48; 95% CI, 0.3-0.78; P =.005). The overall response rate was 26% with panitumumab plus sotorasib at 960 mg (1 complete response and 13 partial responses) and 0% in the SOC arm. The median overall survival was not reached with panitumumab plus sotorasib at 960 mg and was 10.3 months with SOC (HR, 0.7; 95% CI, 0.41-1.18), a non-significant difference. The most common adverse events reported with sotorasib at 960 mg in combination with panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. The most common grade 3-4 laboratory abnormalities were decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium. Lumakras is supplied in 120 mg, 240 mg, and 320 mg tablet strengths. The recommended dose of Lumakras for KRAS G12C-mutated metastatic CRC is 960 mg orally once daily in combination with panitumumab until disease progression or unacceptable toxicity. The first dose of Lumakras should be administered before the first panitumumab infusion. In addition to this new indication, Lumakras is approved for use as a single agent to treat adults with advanced non-small cell lung cancer who have KRAS G12C mutations, as determined by an FDA-approved test, and have received at least 1 prior systemic therapy.

FDA approval of acalabrutinib with BR for Mantle cell lymphoma as the first line therapy: The US Food and Drug Administration (FDA) has approved acalabrutinib (Calquence) for use in combination with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplant. The approval was based on data from the phase 3 ECHO trial. The trial (NCT02972840) enrolled 598 adults aged 65 years and older with previously untreated MCL. The patients were randomly assigned 1:1 to receive acalabrutinib plus BR or placebo plus BR. The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee. The median PFS was 66.4 months in the acalabrutinib-BR arm and 49.6 months in the placebo-BR arm (hazard ratio, 0.73; 95% CI, 0.57-0.94; P =.016). The overall response rate was 91% in the acalabrutinib arm and 88% in the placebo arm (P =.220). The complete response rates were 67% and 54%, respectively. Serious adverse events reported with acalabrutinib plus BR included pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia. In addition to the aforementioned approval, the FDA has also granted traditional approval for Calquence to be used as a single agent in adults with previously treated MCL. The drug was granted accelerated approval for this indication in 2017. Calquence is also approved to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The drug is supplied as 100 mg tablets.

FDA approval of SQ nivolumab: The US Food and Drug Administration has approved subcutaneous nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for some of the same indications as intravenous nivolumab (Opdivo). Nivolumab-hyaluronidase is approved to treat adults with renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Nivolumab-hyaluronidase is approved for use as monotherapy and in combination with chemotherapy or cabozantinib but not in combination with intravenous ipilimumab. The approval is supported by results from the CHECKMATE-67T trial. This trial (NCT04810078) included 495 patients with advanced or metastatic clear cell renal cell carcinoma who had received no more than 2 prior systemic therapies. The patients were randomly assigned to receive subcutaneous nivolumab-hyaluronidase (n=248) or intravenous nivolumab (n=247). The predefined acceptance margin for pharmacokinetic endpoints was met. The lower boundary of the 90% confidence interval of geometric mean ratios was not less than 0.8 for both the time-averaged serum concentration of nivolumab over the first 28 days of treatment and the trough serum concentration of nivolumab at steady state. The overall response rate was 24% in the nivolumab-hyaluronidase arm and 18% in the intravenous nivolumab arm. Safety outcomes were generally similar between the arms. The most common adverse events observed were fatigue, musculoskeletal pain, pruritus, rash, and cough. The recommended doses of nivolumab-hyaluronidase vary by indication.

FDA approval of Tislelzumab in combination with platinum and flurouracil as the first line Tx for metastatic gastric or GEJ cancer with + PD-L1 CPS >1 and (-) HER2. The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr) for use in combination with platinum and fluoropyrimidine-based chemotherapy as first-line treatment for unresectable or metastatic, HER2-negative, PD-L1-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval was supported by results from the phase 3 RATIONALE-305 trial. The trial (NCT03777657) included 997 patients with previously untreated, HER2-negative, unresectable or metastatic gastric/GEJ cancer. The patients were randomly assigned to receive tislelizumab or placebo every 3 weeks, each in combination with the investigator’s choice of chemotherapy. Tislelizumab was given until disease progression or unacceptable toxicity. Among patients with a PD-L1 combined positive score greater than 1, tislelizumab significantly improved overall survival (OS) and progression-free survival (PFS). The median PFS was 7.0 months with tislelizumab and 6.4 months with placebo (hazard ratio [HR], 0.77; 95% CI, 0.66-0.90). The median OS was 15.1 months and 12.9 months, respectively (HR, 0.78; 95% CI, 0.67-0.91). The most common adverse events reported with tislelizumab in combination with chemotherapy were nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count , decreased neutrophil count, increased aspartate aminotransferase, diarrhea, abdominal pain, increased alanine aminotransferase, decreased white blood cell count, decreased weight, and pyrexia. Tevimbra is supplied as a 100 mg/10 mL solution in a single-dose vial. It is administered as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity. Dosage modifications may be needed to manage adverse reactions. Tevimbra is also approved to treat patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-L1 inhibitor.

FDA Approves New ADC for HR+, HER2- Breast Cancer: Datopotamab derixican January 17, 2025 -> when compared with other chemo drugs, response rate was better 36 vs 23%, but overall median survival was not different. Datopotamab deruxtecan for the treatment of certain patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Specifically, the novel Trop-2-directed antibody and topoisomerase inhibitor conjugate is indicated for those who have received prior treatment with endocrine-based therapy and chemotherapy for unresectable or metastatic disease, according to the FDA approval notice. This approval - the first in the US for the antibody drug conjugate, which was discovered by Daiichi Sankyo and is being jointly developed with AstraZeneca - was based on findings from the randomized, multicenter, open-label TROPION-Breast01trial of 732 patients who were considered unsuitable for further endocrine therapy and who had received up to two lines of prior chemotherapy. Results showed improved response rates and progression-free survival (PFS) in 365 patients randomized to receive datopotamab deruxtecan (Dato-DXd), compared with 367 randomized to receive investigator’s choice of chemotherapy with eribulin, capecitabine, vinorelbine, or gemcitabine. Median PFS was significantly longer at 6.9 vs 4.9 months in the Dato-DXd and chemotherapy arms, respectively (hazard ratio [HR], 0.63). Median overall survival, at 18.6 and 18.3 months, respectively (HR, 1.01), did not differ significantly in the two arms. The confirmed overall response rate was 36% and 23%, and the median duration of response was 6.7 and 5.7 months in the Dato-DXd and chemotherapy arms, respectively. Adverse reactions occurring in at least 20% of patients, including laboratory abnormalities, were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased alanine aminotransferase, keratitis, increased aspartate aminotransferase, and increased alkaline phosphatase.

Planet Ayurveda is the best! Their Ayurvedic products and treatments for ITP are highly effective. I'm so grateful for their help

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That is the best explanation of the disease i have heard up to now. Thank you

TNBC chemo with immunotherapy cause me to develop hypothyroidism and secondary adrenal Insufficiency. My oncologist has very little experience with this. Now my new endocrinologist also doesn't seem very experienced in treating both together. My question is who should be reporting these side effects to pharmaceutical company? From what I've researched it looks like these side effects are on the rise and not congruent with drug maker's current numbers, resulting in oncologists not being better educated on side effects and when to order further testing.

Where can i get pdf for this lecture??

thank you professor im going through oral exam you have saved me

I was diagnosed with ITP and was struggling to find a natural solution. Thankfully, I discovered Planet Ayurveda and their amazing products! My platelet count has increased significantly since I started using their supplements.

Thank you for making this video.

New ICI for metastatic cutaneous squamous cell carcinoma: Cosibelimab The US Food and Drug Administration (FDA) has approved the immune checkpoint inhibitor cosibelimab (Unloxcyt; Checkpoint Therapeutics, Inc.) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. The programmed death ligand-1 (PD-L1)-blocking antibody is the first and only treatment of its kind approved for advanced CSCC, according to a Checkpoint Therapeutics press release. The FDA approval was based on findings from the multicenter, open-label Study CK-301-101 trial of 109 patients. In that trial, the objective response rate (ORR) was 47% in 78 patients with metastatic CSCC and 48% in 31 patients with locally advanced CSCC. Median duration of response (DOR) in treated patients was not reached in those with metastatic disease and was 17.7 months in those with locally advanced disease, according to the FDA approval notice.

I was diagnosed to have ITP since I was 3. I'm 51 now and still suffering with bruising, headaches, joint pains, fatigue, palpitation. I take prednisone on and off. I detest the side effects. ..

Pls help children whith colon cancer plz they are ding

Durvalumab maintenance therapy up to 2 years approved by FDA in 12/4/24 for Limited Stage Small Cell Lung Cancer (when no progression after induction chemo radiation therapy On Dec. 4, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for adults with limited-stage small cell lung cancer (LS-SCLC) without disease progression after platinum-based chemotherapy and radiation therapy. The approval marks the most significant shift in care for limited-stage SCLC in decades. FDA officials based their decision on results from the double-blind, randomized, placebo-controlled ADRIATIC clinical trial. The phase 3 study included 730 patients with LS-SCLC whose disease did not progress after current platinum-based chemotherapy and radiation. Investigators enrolled patients with stage I-III LS-SCLC or inoperable stage I/II disease, good performance status, and no progression after first-line chemoradiotherapy. After stratification, participants were randomly assigned in a 1:1:1 manner to receive single-agent durvalumab, durvalumab plus tremelimumab (Imjudo), or placebo. The study’s primary endpoints were overall survival (OS) and progression-free survival. A blinded independent central review assessed the comparison between single-agent durvalumab and placebo. Durvalumab elicited a statistically significant OS improvement compared with placebo, with a hazard ratio (HR) of 0.73 (95% confidence interval [CI], 0.57-0.93; P-value=.0104). The median OS was 55.9 months (95% CI, 37.3 months to not reached) in the durvalumab group compared with 33.4 months (95% CI, 25.5-39.9 months) in the placebo group. In addition, durvalumab had a statistically significant PFS improvement compared with placebo, with an HR of 0.76 (95% CI, 0.61-0.95; P-value=.0161). The median PFS was 16.6 months in the durvalumab group (95% CI, 10.2-28.2 months) and 9.2 months in the placebo group (95% CI, 7.4-12.9 months). Data from the ADRIATIC trial were met with applause when they were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in June. Experts at the meeting said the results were practice-changing. “This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” said Lauren Averett Byers, MD, from the University of Texas MD Anderson Cancer Center in Houston, who spoke as a discussant during the meeting. “The next step will be moving beyond one size fits all and moving toward personalized, biomarker-driven approaches for patients with small cell lung cancer.” The most common adverse reactions, which occurred in at least 20% of patients, were pneumonitis or radiation pneumonitis and fatigue. Hypertension was the most common grade 3 or higher adverse event and occurred in about one-third of patients in each group, according to data reported at ASCO 2024.

Nivolumab + AVD prolonged disease free survival when compared with bretuximab vedotin + AVD in Hodgkin’s lymphoma stage III and IV patients. www.nejm.org/doi/10.1056/NEJMoa2405888

Thank you teachear

Thanks Dr. My ferritin level has been above 300 for almost a decade and is now at 600. My doc has never even mentioned it. Should I be concerned and get a second opinion?

Zanidatamb, a bispecific antibody therapy for recurrent/ metastatic HER2 (+) biliary cancer was approved by FDA in November 2024. www.targetedonc.com/view/fda-approves-zanidatamab-in-her2-biliary-tract-cancer

Adding Pembrolizumab to chemo radiation therapy for locally advanced cervical cancer improved overall survival. www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01808-7/abstract

Adjuvant pembrolizumab for 1 yr improved overall survival (doubled to >26 Mon) in High grade urothelial carcinoma ,ie, bladder cancer. www.nejm.org/doi/full/10.1056/NEJMoa2401726

Pembrolizumab adjuvant immunotherapy after surgery for high risk clear cell renal cell carcinoma improved disease free survival. Now it showed to improve overall survival. www.nejm.org/doi/full/10.1056/NEJMoa2312695

Asciminib was approved for CML chronic phase treatment. www.oncologynewscentral.com/article/fda-grants-accelerated-approval-to-asciminib-for-chronic-myeloid-leukemia

Thankyou sir so much....very well explained.

Could you please answer, my cbc fluctuates 4 months ago my hb was 11.8 and rbc was 4.6 now my hb is 12.8 and rbc are 5.7 my mch is always low. I’m a female

Dr. What food is good for breakfast , lunch and diner for metastasis in liver. My father have metastasis liver. Please help me

I have nsclc stage 3b lung cancer. I see the oncologist tomorrow, I don't know what I'm going to do. I'm really nervous.

Helo sir, My name is sajid Hussain from pakistan. I have high platelets 900 for last three year's. I take medicine hydruxyurea 500mg morning 500 mg night with loprin 75. But not good result. Now doctor told me i have essential thrombocythemia And change medicine now only loprin 75. Now i have back pain and muscles pain .please suggest me what can I do for best.can i take multivitamins or not.please reply me sir please.

❤😊 Thank you so much 🙏

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hello doctor! my father has adenocarcinoma having size 7 cm*7.3 cm, in biopsy ck7, ttf 1 and napsin a, declared adenocarcinoma, EGFR mutation not detected, >5% invasive, currently chemotherapy is in progress please guide us what to do further, God bless you

My husband has Been diagnosed with squamous cell carcinoma 3b, T4N2M0 in June 2024, his treatment was delayed until October as he had a pulmonary embolism, he had vats surgery which was unsuccessful 😢he has just had 2nd round today of carboplatin and paclitaxel, they said he has no biomarkers, he is 57 we are totally confused, they said they cannot do radiation either because the tumour is close to his heart, he is due a CT scan in the next 2 weeks, feeling very scared 😢

Updated ASCO Guidelines for HR+, HER2- metastatic breast cancer. One caveat is for For PIK3CA-mutated MBC: Alpelisib in combination with ET should be offered to postmenopausal patients Capivasertib plus endocrine therapy was recommended for patients whose tumors harbor PIK3CA or AKT1 mutations or PTEN inactivation. Patients with PIK3CA mutations can be considered for treatment with alpelisib, but patients with AKT1 mutations should not be. ascopubs.org/doi/10.1200/JCO.21.01392

What an excelent video sir

Thank you for taking the time to explain HCC and treatment options. I'm scheduled to have my biopsy in the morning and this has prepared me for the results and treatment plan.

is this suitable for a patient whose immune system is weak? Or what do you recommend?

FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer The FDA has approved zolbetuximab (Vyloy, Astellas Pharma) in combination with fluoropyrimidine and platinum-containing chemotherapy ( FOLFOX or CAPOX) for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2 positive. FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to identify claudin 18.2-positive tumors and thus patients who may be eligible to receive zolbetuximab. Zolbetuximab is the first claudin 18.2-targeting agent approved in the United States. Claudin 18.2 - a cell surface protein prominent in the stomach lining and associated with tumor growth and progression - is overexpressed in about 40% of gastric and gastroesophageal junction tumors. Zolbetuximab binds claudin 18.2 and triggers immune responses that kill the cancer cells. The FDA approval was based on two international phase 3 trials - SPOTLIGHT and GLOW. Across the 565 patients in SPOTLIGHT, adding zolbetuximab to mFOLFOX6 chemotherapy led to a significant improvement in median overall and progression-free survival. Patients who received zolbetuximab with mFOLFOX6 chemotherapy demonstrated a median overall survival benefit of almost 3 months - 18.2 months in the zolbetuximab-chemotherapy arm vs 15.5 months in the chemotherapy-placebo group (hazard ratio [HR], 0.750). Median progression-free survival was 10.6 months in the zolbetuximab plus mFOLFOX6 arm vs 8.7 months in mFOLFOX6 plus placebo arm (HR, 0.751). In GLOW, 507 patients were randomly assigned to either zolbetuximab with CAPOX chemotherapy or placebo with CAPOX. Adding zolbetuximab to CAPOX also led to a significant improvement in overall and progression-free survival. Median overall survival was 14.4 months in the zolbetuximab arm vs 12.2 months in the CAPOX-only group (HR, 0.771), and median progression-free survival was 8.2 months in the zolbetuximab arm vs 6.8 months in the CAPOX-only group (HR, 0.687). The incidence of serious adverse events was similar between the zolbetuximab and placebo arms in both trials. Nausea, vomiting, and decreased appetite were the most common side effects, and were substantially more likely with zolbetuximab add-on. The recommended zolbetuximab dosage with fluoropyrimidine- and platinum-containing chemotherapy is 800 mg/m2 intravenously for the first dose, and 600 mg/m2 intravenously every 3 weeks or 400 mg/m2 intravenously every 2 weeks for subsequent doses.

FDA Approves Inavolisib for HR+, HER2−, Advanced Breast Cancer With PIK3CA Mutation The FDA has approved inavolisib (Itovebi, Genentech) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), locally advanced or metastatic breast cancer following recurrence on or after adjuvant endocrine therapy. The FDA also approved the FoundationOne Liquid CDx assay to identify patients who qualify for the newly approved treatment. The oncogenic PIK3CA mutation is found in approximately 40% HR+ metastatic breast cancers. Novartis' alpelisib (Piqray) also targets the mutation and carries a similar breast cancer indication for combination with fulvestrant. Previous studies showed better efficacy (due to dual blockage of PIK3CA alpha isoform and protein of inavolisib vs. single PIK3CA alpha isoform of alpelisib) and less side effects. Approval of inavolisib was based on the INAVO120 trial, which randomized 325 qualifying patients equally to receive either inavolisib 9 mg or placebo orally once daily on a background of palbociclib and fulvestrant in 28-day treatment cycles. Patients had progressed during or within 12 months of completing adjuvant endocrine therapy and had not received prior systemic therapy for locally advanced or metastatic disease. Median investigator-assessed progression-free survival was 15 months with inavolisib vs 7.3 months with placebo (hazard ratio, 0.43; P < .0001). The objective response rate (ORR) was 58% and median duration of response (DOR) was 18.4 months in the inavolisib arm vs an ORR of 25% and DOR of 9.6 months in the placebo arm. An interim analysis of overall survival did not reach statistical significance but favored inavolisib. The most common adverse reactions with inavolisib, occurring in 20% or more of patients, were decreased neutrophils, hemoglobin, platelets, lymphocytes, calcium, potassium, sodium, magnesium, and appetite; increased fasting glucose, creatinine, and alanine aminotransferase; stomatitis; diarrhea; fatigue; nausea; rash; SARS-CoV-2 infection; and headache. The recommended inavolisib dose is 9 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Pricing information wasn't available at press time; 56 tablets of alpelisib, also administered daily, costs $23,217.11, according to drugs.com.

Any information about ret fusion mutation in metastatic adenocarnimo lung with brain. Mets