Proactive’s Post

Johnson & Johnson has submitted a biologics license application (BLA) to the FDA for a new lung cancer treatment. Let’s dive into the details: The Treatment: A new subcutaneous (SC) form of amivantamab for non-small cell lung cancer (NSCLC). What’s Unique: This SC option, administered in just five minutes, could transform the treatment experience for patients, oncologists, and nursing staff. Clinical Trial Results: SC amivantamab demonstrated a comparable overall response rate to intravenous administration in patients with NSCLC harboring EGFR exon 19 deletion or L858R mutations. Recent Approvals: The FDA recently approved intravenous RYBREVANT in combination with chemotherapy for first-line treatment of NSCLC with EGFR exon 20 insertion mutations. Why It Matters: This advancement opens new possibilities for lung cancer patients, improving their quality of life and treatment options. Let’s spread the word about this medical breakthrough! #lungcancertreatment #lungcancer #cancerresearch https://lnkd.in/gnGtVuSe

US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors :- •<The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo opens new tab and AstraZeneca's (AZN.L), opens new tab drug to treat patients with a type of solid tumor. •The drug, sold under the brand name Enhertu, originally won U.S. approval in late 2019 as a third-line treatment for HER-2-positive breast cancer patients, and the fresh approval opens the treatment across multiple HER2-expressing solid tumors. •HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, according to AstraZeneca. •The drug showed clinically meaningful survival benefits in previously treated patients in three mid-stage trials.

Bristol Myers Squibb Gets USFDA Accelerated Approval For Krazati, Cetuximab Combo For Colorectal Cancer Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. #bristolmyerssquibb #bristolmyerssquibbnews #USFDA #krazati #adagrasib #colorectalcancer #fluoropyrimidine#oxaliplatin

📢 FDA approves amivantamab in first-line EGFR exon 20 insertion-mutated non-small cell lung cancer indications; converts to traditional approval (The Janssen Pharmaceutical Companies of Johnson & Johnson) ➤ Amivantamab + carboplatin +pemetrexed showed a statistically significant improvement in PFS vs. carboplatin + pemetrexed with a HR of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). Median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms ➤ FDA action converts the May 2021 2nd line accelerated approval to a full approval based on the confirmatory Phase 3 PAPILLON study #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent #nsclc https://lnkd.in/estqwicD

Ahead of an advisory committee meeting scheduled for Thursday, FDA staffers have raised concerns of overtreatment with AstraZeneca’s Imfinzi in its Phase III study in non-small cell lung cancer. In a joint briefing document with the pharma, the regulator’s internal reviewers noted that AstraZeneca’s approach of giving Imfinzi perioperatively—both before and after surgical resection of the tumor—could have exposed patients to excessive levels of immune checkpoint inhibitors. The FDA’s Oncologic Drugs Advisory Committee will meet on Thursday to review the “high uncertainty around the contribution of phases,” especially the need for adjuvant Imfinzi on top of neoadjuvant chemoimmunotherapy. #biotech #biopharma #pharma #NSCLC #Imfinzi #Adcomm

In February three FDA approvals received a lot of attention from HCPs. The first was the BioTherapeutics Inc. first cellular therapy to treat patients with unresectable or metastatic melanoma. The second was AstraZeneca's Tagrisso (osimertinib), for patients with EGFR-mutated non-small cell lung cancer and lastly, the third was Genentech's Xolair (omalizumab) injection to help reduce allergic reactions to multiple foods after accidental exposure. Read what HCPs say about these new treatments via the link in the comments. Better listening for better health. https://bit.ly/49aDMSp #pharmaceuticals #healthcare #medicine

📢 FDA approves osimertinib for locally advanced, unresectable (stage III) NSCLC following chemoradiation therapy ➤ Tagrisso (osimertinib, AstraZeneca), for adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test ➤ Efficacy was evaluated in LAURA (NCT03521154), a double blind, randomized, placebo-controlled trial in 216 adult patients ➤ Osimertinib demonstrated a statistically significant improvement in PFS vs. placebo with a hazard ratio of 0.16 (95% CI: 0.10, 0.24; p-value <0.001). The median PFS was 39.1 months (95% CI: 31.5, not estimable [NE]) in the osimertinib arm and 5.6 months (95% CI: 3.7, 7.4) in the placebo arm ➤ While OS results were immature at the current analysis, with 36% of pre-specified deaths for the final analysis reported, no trend towards a detriment was observed #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/eECxiacc

FDA approves BeiGene’s TEVIMBRA for oesophageal cancer The FDA's decision is supported by results from the RATIONALE 302 trial, a global, randomised, open-label Phase III study. The US Food and Drug Administration (FDA) has approved BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy. The approval for TEVIMBRA as monotherapy comes as a significant advancement for patients who have not previously been treated with a PD-(L)1 inhibitor. A humanised immunoglobulin G4 anti-programmed cell death protein 1 monoclonal antibody, TEVIMBRA is set to become available in the US in the second half of 2024. The FDA’s decision is supported by results from the RATIONALE 302 trial, a global, randomised, open-label Phase III study. It assessed the efficacy and safety of TEVIMBRA versus the investigator’s choice of chemotherapy in 512 patients across 132 research sites in 11 countries. https://lnkd.in/eNmfc82b