Bristol-Myers' Opdivo+Yevroy Application Gets EMA Validation
Bristol Myers Squibb BMY announced that the European Medicines Agency (EMA) validated a type II variation application for its PD-L1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). Validation of the application confirms that the submission is complete and marks the beginning of the EMA’s centralized review process. MPMis a rare but aggressive form of cancer that forms in the lining of the lungs.
The type II variation application is supported by data from the pivotal phase III CheckMate -743 study, which met the primary endpoint of superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients. We note that Opdivo is currently approved in many regions, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. The Opdivo + Yervoy combination is already approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma. The combination is also indicated for the treatment of adults and pediatric patients 12 years or older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and for HCC.
In May, the FDA granted approval to Opdivo + Yervoy combination with limited chemotherapy as a first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. In the same month, the FDA also approved Opdivo + Yervoy as a first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1≥1%.
However, Opdivo faces stiff competition from Merck’s MRK Keytruda,Roche’s RHHBY Tecentriq and AstraZeneca’s AZN Imfinzi in its various approved indications.
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