Bristol-Myers Squibb announced that it will not pursue an accelerated regulatory pathway for the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line lung cancer in the US based on a review of current data. The company said that it will not be "providing additional details" at this time, adding that "all first-line lung registrational studies continue."
Commenting on the decision, Jefferies analyst Jeffrey Holford said that he expects the combination of the PD-1 inhibitor and the CTLA-4 inhibitor to be approved in the second half of 2018 and sees "no real change to valuation or estimates as a result of this update." However, shares in Bristol-Myers Squibb fell as much as 6 percent on the news. For further analysis, read ViewPoints: Bristol-Myers Squibb concedes more ground in PD-1 lung cancer race.
Opdivo is currently approved in the US for the treatment of patients with metastatic non-small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as a number of other tumour types, including melanoma, renal cell carcinoma and head and neck cancer.
FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Earlier this month, the FDA accepted a filing from Merck & Co. seeking approval of its anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy for the first-line treatment of patients with metastatic or advanced non-squamous NSCLC regardless of PD-L1 expression and with no EGFR or ALK genomic tumour aberrations. The agency granted the application priority review with a target action date of May 10.
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