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)
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
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