Drug Approval | March 06, 2022
USFDA approves expanded use of Bristol Myers Opdivo
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung 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.
It is a Phase 3 ready anti-myostatin adnectin for Spinal Muscular Atrophy (SMA).
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
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
Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter
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