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Non-Small Cell Lung Cancer News (Page 5)
Related terms: Cancer, Lung, Non-Small Cell, Lung Cancer, Non-Small Cell, NSCLC
FDA Approves Braftovi (encorafenib) with Mektovi (binimetinib) for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation
NEW YORK--(BUSINESS WIRE) October 12, 2023 – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) + Mektovi® (binimetinib) f...
FDA Grants Regular Approval for Gavreto (pralsetinib) for Non-Small Cell Lung Cancer with RET Gene Fusions
On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET)...
FDA Approves Keytruda (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)
Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based...
Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for Pemfexy in Combination with Pembrolizumab and Platinum Chemotherapy
Additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations Represents the fifth indication...
FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
SAN DIEGO, Dec. 12, 2022 /PRNewswire/ – Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted ...
Imfinzi and Imjudo with Chemotherapy Approved in the US for Patients with Metastatic Non-Small Cell Lung Cancer
Approval based on POSEIDON Phase III trial results, which showed significant survival benefit with a limited course of Imjudo added to Imfinzi and chemotherapy 11 November 2022 – AstraZeneca’s I...
Libtayo (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)
Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide range of disease characteristics Second advanced NSCLC...
FDA Approves Vegzelma (bevacizumab-adcd), a Biosimilar to Avastin
Vegzelma is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA Vegzelma offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment option ...
Enhertu Approved in the US as the First HER2-Directed Therapy for Patients with Previously Treated HER2-Mutant Metastatic Non-Small Cell Lung Cancer
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease 12 August 2022 – A...
FDA Approves Alymsys (bevacizumab-maly), a Biosimilar to Avastin
BRIDGEWATER, N.J.--(BUSINESS WIRE) April 13, 2022 --Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved ...
U.S. Food and Drug Administration Approves Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer
Approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer1 In the Phase 3 CheckMate -816 trial, Opdivo plus platinum-doublet chemotherapy...
FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer
Tecentriq is the first and only cancer immunotherapy approved for treatment of NSCLC in the adjuvant setting Approval based on the Phase III IMpower010 study showing adjuvant Tecentriq improved...
FDA Approves Exkivity (mobocertinib) for EGFR Exon20 Insertion+ Non-Small Cell Lung Cancer (NSCLC)
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE) September 15, 2021 --Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (F...
FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult...
FDA Approves Rybrevant (amivantamab-vmjw) as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of Rybrevant (...