BMS Gets First Immunotherapy Approval In Neoadjuvant Lung Cancer, Quickly
Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.
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The company stopped a study of Lynparza in colorectal cancer for futility and announced a study of Keytruda/chemoradiation in head-and-neck cancer didn’t meet its primary endpoint.
Without disclosing data, the company reported positive pathological complete response data from the AEGEAN study of its PD-L1 inhibitor Imfinzi in neoadjuvant NSCLC, where BMS’s Opdivo won approval in March.
The company credited generics’ late market entry, but that benefit is not expected to last; the firm lowered guidance for annual sales of the oncologic.