In CheckMate -577, Opdivo
1
Approval expands the role of Opdivo in earlier stages of disease, with two indications in the adjuvant setting across three types of cancer
1
PRINCETON, NJ, USA I May 20, 2021 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Opdivo
® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
1 The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated
Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
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1 1,2 as a standard of care for intermediate- or poor-risk patients 3 OPDIVO ® (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with CABOMETYX ® (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). 1 The approval is based on the Phase 3 CheckMate -9ER trial, which compared OPDIVO in combination with CABOMETYX (n=323) versus sunitinib (n=328) in patients with advanced RCC. 1 This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.
Search jobs 19-Jan-2021 Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis
Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis
Company Announcement
®
(daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
Accelerated approval of DARZALEX
Genmab to receive USD 30 million milestone payment on first commercial sale
Copenhagen, Denmark; January 15, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX