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Non-Small Cell Lung Cancer News (Page 6)
Related terms: Cancer, Lung, Non-Small Cell, Lung Cancer, Non-Small Cell, NSCLC
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 (...
U.S. FDA Expands Approval of Pfizer’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer
NEW YORK--(BUSINESS WIRE) March 03, 2021 – The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for Lorbrena® (lorlatinib), ex...
FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression
RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) – G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration...
FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%
TARRYTOWN, N.Y. and PARIS, Feb. 22, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-...
FDA Approves Tepmetko (tepotinib) as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations
ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/ – EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug...
Tagrisso Approved in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer
21 December 2020 – AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non...
FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
South San Francisco, CA – September 4, 2020 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Takeda’s Alunbrig (brigatinib) as a First-Line Treatment Option for Patients with ALK+ Metastatic Non-Small Cell Lung Cancer (NSCLC)
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE) May 22, 2020 --Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved...
FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%
PRINCETON, N.J.--(BUSINESS WIRE) May 15, 2020 --Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was...