番茄社区app

Genentech announced that it will of the PD-L1 inhibitor atezolizumab (Tecentriq), in combination with nab-paclitaxel (Abraxane), for metastatic PD-L1-positive triple-negative breast cancer (TNBC).

The decision was made despite a vote of support by an FDA advisory committee to maintain the accelerated approval in the absence of compelling data to support the results that led to the conditional approval. Since that committee meeting, the company discussed possible postmarketing research requirements (PMR) with the FDA, but "due to changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval."

"TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years," Levi Garraway, MD, PhD, chief medical officer at Genentech and head of Global Product Development, said in a statement.

The decision does not affect the approval of atezolizumab plus nab-paclitaxel in metastatic, PD-L1-positive TNBC.

The FDA granted accelerated approval of atezolizumab and nab-paclitaxel on the basis of the IMpassion130 trial, which showed significant improvement in progression-free survival and "clinically meaningful" improvement in overall survival in patients with PD-L1-positive metastatic TNBC versus chemotherapy alone. The follow-up phase III IMpassion131 trial was designed to fulfill PMR and create a path to full approval. Instead, IMpassion131 failed to achieve significant improvement in progression-free or overall survival.

Despite the lack of corroborating evidence from IMpassion131, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 7-2 to recommend that the FDA maintain accelerated approval of atezolizumab and nab-paclitaxel for PD-L1-positive metastatic TNBC.

Reflecting the prevailing sentiment about the vote, ODAC panelist Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute in Boston, explained his affirmative vote as "a difficult decision in a very difficult disease to treat. I have spent decades caring for these patients, and we all wish we had fundamentally better options."

Last month, the FDA converted an accelerated approval to full approval for pembrolizumab (Keytruda) plus chemotherapy for unresectable/metastatic TNBC associated with PD-L1 expression ≥10%.

Comment