FDA Committee Recommends Continuing Accelerated Approval Status of Tecentriq in Certain Patients with Metastatic Triple-Negative Breast Cancer

Members of an FDA committee voted in favor of Tecentriq plus Abraxane keeping its accelerated approval for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.

A panel of Food and Drug Administration (FDA) committee members voted 7-to-2 in support of continuing the accelerated approval of Tecentriq (atezolizumab) with Abraxane (nab-paclitaxel) for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1, as determined by an agency-approved test.

The FDA has not indicated when it will make a final decision on this indication of Tecentriq.

“People with triple-negative breast cancer have few treatment options, which is why today’s committee decision to recognize the importance of this Tecentriq combination is significant,” said Dr. Levi Garraway, chief medical officer and head of global product development at Roche, in a news release. “We are grateful to the FDA and (Oncologic Drugs Advisory Committee) for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer.”

The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting was a part of a series of reviews by the agency of six accelerated drug approvals that have failed to show a certain improvement in confirmatory trials and have yet to receive full approval.

The FDA granted the Tecentriq and Abraxane combination an accelerated approval in March 2019 as the agency deemed the treatment was worthy of a conditional approval as it filled an unmet medical need for this patient population. The agency’s decision was based on data from the multi-center, international phase 3 IMpassion130 trial, in which demonstrated that the addition of Tecentriq to Abraxane reduced the risk of death or disease progression by 40% compared to Abraxane alone in adults with unresectable, locally advanced or metastatic TNBC.

Moreover, Tecentriq plus Abraxane induced a median progression-free survival of 7.4 months compared to 4.8 months in those who received placebo plus Abraxane. And, the objective response rate (the percentage of patients with partial and complete responses to treatment) in patients with confirmed responses was 53% in the Tecentriq group, compared to 33% in the placebo group.

“As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication,” the company stated in its release.

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