FDA says no to two more cancer drugs developed in China –

The FDA has refused to approve two other cancer therapies developed by China-based drugmakers, which could be further evidence of a tough line taken by the regulator for drugs being tested outside the United States.

The agency has sent a complete response letter (CRL) to Hutchmed stating that its application to market surufatinib, a multikinase inhibitor, for advanced neuroendocrine tumors (NETs) has been rejected, and that the company will need to conduct a new trial to provide evidence that the drug works in a US patient population.

Meanwhile, the FDA also rejected Coherus and Shanghai Junshi Biosciences’ PD-1 inhibitor toripalimab for nasopharyngeal carcinoma (NPC), after challenging the drug‘s manufacturing – specifically asking for a quality process change.

In Hutchmed’s case, the CRL was issued for reasons similar to those that sabotaged Innovent/Eli Lilly’s PD-1 inhibitor sintilimab, which was denied in February with a request for more “applicable data.” to the American people and to the United States”. medical practice.”

Hutchmed had been seeking US approval based on two positive Phase 3 trials in China as well as a smaller “bridge” study being conducted in the US, but said the FDA insists on the fact that a multi-regional clinical trial will be needed – likely leading to a major delay to the cancer drug in the United States.

The company has applied for approval of surufatinib for pancreatic and extra-pancreatic NETs, ​​two indications already approved by Chinese regulatory authorities and for which few treatment options are available.

Hutchmed is also relying on bridging studies to try to get surufatinib approved in Europe, where the drug has already been filed, as well as in Japan where a study is underway.

For Coherus and Junshi, the setback seems easier to remedy, as both partners expressed confidence that the required process change can be implemented easily, allowing them to re-apply for approval around the middle of this year. .

They requested approval of toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic PCN, and as monotherapy for the second-line treatment of advanced PCN after chemotherapy with platinum base.

Coherus Chief Executive Officer Denny Lanfear was quick to emphasize that the FDA is satisfied with the toripalimab clinical data submitted in the filing, and noted that the FDA will conduct a review six months after the refiling.

There are no approved cancer immunotherapies for NPC in the United States, said, adding, “The FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of clinical data from a single country. .”

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