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CompilationTom Lee
A few days ago, Bristol-Myers Squibb stated that it would voluntarily withdraw Opdivo's indication approval for hepatocellular carcinoma patients who have previously received Nexavar treatment and have failed the treatment
.
After the failure of the confirmatory test of the drug in the clinical real environment, the FDA has raised concerns about the use of Opdivo in second-line liver cancer
.
In the CheckMate-459 trial, the PD-1 inhibitor Opdivo failed to significantly extend the survival time of newly diagnosed liver cancer patients compared with Nexavar
In 2017, the FDA accelerated the approval of the new indication of Opdivo for hepatocellular carcinoma patients who had previously received Nexavar treatment
.
The FDA approval is mainly based on the test results of the CheckMate-040 study
In a previous statement, Bristol-Myers Squibb’s head of oncology development, Jonathan Cheng, said the company was "disappointed" by the advisory committee and the FDA's "stance" on patients with liver cancer following Opdivo's use of Nexavar
.
He pointed out that single-drug application of Opdivo is currently the most commonly used therapy in clinical practice
At present, Opdivo's prospects for second-line treatment in the field of liver cancer have not been completely dashed
.
The combination of the drug and Yervoy, another CTLA-4 inhibitor from Bristol-Myers Squibb, received accelerated approval for this indication in March 2020, and is not affected by Opdivo's withdrawal of this single-agent indication
The results of the trial showed that after a minimum follow-up of 28 months, the objective response rate (ORR) of patients treated with the combination of Opdivo and Yervoy was 31%, the complete response rate (CR) was 8% (4/49), and the partial response rate ( PR) was 24% (12/49), the median duration of response (DoR) was 17.
5 months, and 88% of patients in remission lasted more than 6 months
.
A phase 3 trial called CheckMate-9DW is now confirming the benefits of this dual immunotherapy
It is worth noting that, as of now, a number of anti-PD-(L)1 therapies have been voluntarily withdrawn for accelerated approval indications in the United States
.
In June, Merck abandoned Keytruda's third-line treatment for SCLC indications
Reference source: Bristol Myers, yielding to FDA pressure, pulls Opdivo in post-Nexavar liver cancer
