Drug Approval | June 14, 2022
FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
Researchers found that the drug combination led to a sustained and tenfold increase in the production of CD8 T cells and natural killer cells
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region
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
Shanghai Roche Pharmaceuticals and Shanghai KeChow Pharma, entered into a cooperation agreement to improve market access of Zelboraf in China.
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