Potential FDA Cancer Drug Approvals on the Horizon This Spring


The Food and Drug Administration plans on reviewing multiple new cancer therapies this spring.

When a cancer treatment shows promise in clinical trials, the pharmaceutical company will ask for it to be reviewed by the Food and Drug Administration (FDA). The agency will usually then set a date by which it plans to review the regimen and decide if it will be approved.

CURE® took inventory of some of the upcoming FDA decision dates for new cancer therapies. Here’s a roundup of what to expect in the second quarter (March through May) of 2022:

Toripalimab plus chemotherapy in the frontline or without chemotherapy in the second- and third-line setting for recurrent or metastatic nasopharyngeal carcinoma.

Findings from the phase 2 POLARIS-02 trial demonstrated that 20.5% of patients with previously treated recurrent or metastatic nasopharyngeal carcinoma saw their disease shrink as a result of treatment.

The phase 3 JUPITER-02 trial, meanwhile, showed that the average time between treatment with toripalimab plus gemcitabine and cisplatin to worsening disease (known as progression-free survival) was 11.7 months. This was better than the progression-free survival average of eight months seen with chemotherapy alone.

The FDA plans on making its decision on toripalimab by April 30, 2022.

Surufatinib for patients with advanced neuroendocrine tumors.

Neuroendocrine tumors (commonly referred to as NETs) are cancers that arise in the neuroendocrine cells, which are similar to nerve and hormone-producing cells and can appear anywhere throughout the body.

After findings from the phase 3 SANET-ep clinical trial showed significantly longer progression-free survival for patients given surufatinib compared with those given placebo, the trial was able to stop early. Similarly, the phase 3 SANET-p trial showed a progression-free survival of 10.9 months versus 3.7 months in the surufatinib and placebo groups, respectively. That trial was terminated early, too.

The FDA plans on making its decision on surufatinib by April 30, 2022.

Opdivo (nivolumab) plus Yervoy (ipilimumab) and Opdivo plus chemotherapy for advanced esophageal squamous cell carcinoma.

In the global, phase 3 CheckMate-648 clinical trial, both Opdivo-based regimens improved survival compared with chemotherapy alone in patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma whose tumors expressed PD-L1 levels of 1% or higher.

Opdivo works by blocking PD-1, a protein on immune cells attached to PD-L1 on cancer cells and prevents the immune cells from attacking the cancer. By blocking PD-1, the immune system will find and attack the tumors.

The FDA plans on making its decision on Opdivo plus Yervoy and Opdivo plus chemotherapy by May 28, 2022.

Enhertu (trastuzumab deruxtecan) for pretreated metastatic HER2-positive breast cancer.

In the DESTINY-Breast03 trial, there was a 72% reduction in the risk of disease progression or death compared with Kadcyla (ado-trastuzumab emtansine) in patients with HER2-positive unresectable and/or metastatic breast cancer that was previously treated with Herceptin (trastuzumab) and a taxane.

Trial results also showed that 94.1% of patients given Enhertu were alive one year after treatment, and 79.7% responded to the treatment. After these findings were presented, one expert said that Enhertu has the potential to be the next standard of care in the space.

The FDA plans on making its decision on Enhertu by the end of the first quarter of 2022 (June 30, 2022).

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