Bristol-Myers Squibb won't seek accelerated US approval of Opdivo, Yervoy combination in first-line

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.

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.