Bristol-Myers Squibb liver cancer drug combo gets FDA approval

pharmafile | March 12, 2020 | News story | Business Services Bristol; Myer Squibb, FDA, FDA BSM, FDA approvals 

The FDA announced on Wednesday that it approved Bristol-Myers Squibb’s Opdivo in combination with Yervoy to treat patients with hepatocellular carcinoma (HCC).

The regulatory body based its approval on the results of the Checkmate-040 clinical study. The trail had patients with HHC who were resistant to other treatments and were tested with the drug combination.

Data from the trial showed that after a minimum of 28 months, the combination elicited a response in 16 of 49 patients (33%) clearing tumours completely in four patients. Responses to the treatment lasted at least six months in 88% of patients and 56% felt the tumour-suppressing benefits for at least a year.

This isn’t the only condition Bristol Myers Squibb has been testing the combination of drugs on. It also had positive results in treating previously untreated kidney cancer, allowing 56% of its trial patients to live beyond 42 months. However, the company was also forced to withdraw an application of the combination for first-line non-small cell lung cancer setting in Europe. Regulators found it impossible to evaluate the data due to changes in the design of the key clinical trial.

Conor Kavanagh

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