- The FDA kicked off a three-day meet to reexamine the accelerated approvals of immuno-oncology drugs with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals.
- FDA’s Oncologic Drugs Advisory Committee (ODAC) started the meet with Roche Holdings AG’s RHHBY Tecentriq, a PD-L1 inhibitor.
- Members voted 7-2 to keep alive the accelerated approval for Tecentriq (atezolizumab) plus Abraxane (nab-paclitaxel) in metastatic triple-negative breast cancer (mTNBC) while additional confirmatory trials are ongoing.
- Tecentriq initially won its accelerated approval in combination with nab-paclitaxel in March 2019 based on a median progression-free survival (PFS) of 7.4 months, compared with 4.8 months on placebo in combo with nab-paclitaxel.
- Steve Chui, global development lead in oncology, spelled out both the benefit from the initial trial and how the confirmatory trial did not show a PFS benefit.
- The confirmatory trial did not pan out and even showed not-so-great signs as the placebo outperformed the treatment combo in terms of overall survival.
- The confirmatory trial showed that 101 of those on placebo and paclitaxel had a median of 28.3 months of overall survival, compared with 22.1 months for 191 of those on atezolizumab and paclitaxel.
- The FDA said in its briefing documents that “it is not yet clear which of these trials are sufficiently designed to adequately confirm benefit,” and Ad Com panelists questioned why one of the trials would use different chemotherapies if it’s a confirmatory trial for Tecentriq and nab-paclitaxel.
- The majority of members still voted to keep the indication under accelerated approval. See the FDA briefing documents.
- Price Action: RHHBY shares are down 1.03% at $41.42 in the premarket on the last check Wednesday.
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