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Imfinzi Approved in US for Less-Frequent, Fixed-Dose Use americanpharmaceuticalreview
December 08, 2020
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy ..
EMA validates Merck’s application to review tepotinib for lung cancer pharmaceutical-technology
November 30, 2020
The European Medicines Agency (EMA) has validated Merck’s application for reviewing tepotinib as a treatment for adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 ...
European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations prnasia
November 27, 2020
Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) ...
FDA approves new dosing option for AZ’s Imfinzi pharmatimes
November 25, 2020
The US Food and Drug Administration (FDA) has approved AstraZeneca’s (AZ) checkpoint inhibitor Imfinzi for an additional dosing option.
Catalent, Blueprint Enter GAVRETO Commercial Supply Pact contractpharma
November 24, 2020
Following FDA approval and tech transfer, the Catalent team in Kansas City will support commercial supply of the non-small cell lung cancer drug.
CStone Pharmaceuticals Announces China's NMPA has Accepted its New Drug Application for anti-PD-L1 Monoclonal Antibody Sugemalimab in First-Line Advanced NSCLC prnasia
November 12, 2020
CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, announced that China's National Medical Products Administration (NMPA) has accepted ..
FDA Accepts for Priority Review Libtayo for Advanced Non-small Cell Lung Cancer americanpharmaceuticalreview
November 09, 2020
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with ...
Bristol Myers Squibb get EC approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with chemotherapy for metastatic NSCLC expresspharma
November 09, 2020
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinoma.
AZ’s Tagrisso scores priority review from FDA pharmatimes
October 22, 2020
AstraZeneca’s EGFR-tyrosine kinase inhibitor Tagrisso has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of early-stage EGFR-mutated lung cancer.
BMS' Opdivo wins new NICE lung cancer backing pharmatimes
September 21, 2020
NICE has published draft guidance recommending Bristol-Myers Squibb's Opdivo (nivolumab) as a second-line treatment option for patients with squamous or non-squamous non-small-cell lung cancer (NSCLC).

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