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FDA's ODAC Favors Maintaining Tecentriq Accelerated Approval in Triple-Negative Breast Cancer Subset

NEW YORK – The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) on Tuesday voted to keep in place the accelerated approval for Genentech's checkpoint inhibitor atezolizumab (Tecentriq) in combination with chemotherapy for unresectable or advanced triple-negative breast cancer patients whose tumors express PD-L1.

The agency's expert committee is meeting this week to review the risks and benefits of maintaining market access to several immunotherapy drug indications that the FDA conditionally approved on an accelerated clip based on early data, but then subsequent confirmatory trials of these drugs failed to meet their primary endpoints hindering conversion to regular approval. The PD-L1 positive triple-negative breast cancer indication for Genentech's atezolizumab in combination with paclitaxel protein-bound is among the indications on ODAC's review docket.

After reviewing the data yesterday, ODAC voted to maintain accelerated approval status — seven in favor and two against — in this setting, recognizing that TNBC patients lack treatment options. The FDA doesn't have to take up the recommendations of its advisory committee members, though the agency generally does so.

The FDA granted accelerated approval for atezolizumab plus paclitaxel protein-bound in March 2019 for PD-L1-positive, advanced triple-negative breast cancer based on data from the IMpassion130 study, which showed that patients receiving the combination had a median progression-free survival of 7.5 months compared to 5 months for those on just chemotherapy.

Continued approval of this indication, however, was contingent on positive results from the confirmatory IMpassion131 trial, which did not meet its primary endpoint. Among 651 patients, 45 percent had PD-L1-positive metastatic disease, and in this group, the median progression-free survival was 6 months and 5.7 months for those receiving atezolizumab plus chemo or only chemo, respectively.

"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," Levi Garraway, chief medical officer and head of Genentech's global product development, said in a statement. "We are grateful to the FDA and ODAC for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer."