Drug Approval | February 18, 2022
USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
Focused medicines company delivering strong operational performance. Building depth in five core therapeutic areas, strength in technology platforms, and a balanced geographic footprint
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
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