The manufacturers of the drug plan to resubmit the request for the FDA to approve the regimen sometime this summer.
The Food and Drug Administration (FDA) recently rejected a request from Coherus BioSciences and China-based Junshi Biosciences to introduce an investigational drug combination into the United States market as a first-line treatment option for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, a type of head and neck cancer.
Moreover, the FDA rejected a request to approve toripalimab as a single-agent treatment in patients whose disease failed to respond to platinum-containing chemotherapy.
The investigational drug, toripalimab, was being investigated in combination with the chemotherapy’s gemcitabine and cisplatin as an initial treatment option for patients with advanced recurrent or metastatic nasopharyngeal carcinoma.
The two companies, according to a press release, plan to meet with the FDA to address the issues raised by the agency when it rejected the request. Coherus and Junshi announced that the two companies plan to resubmit the request for approval sometime in the summer. In its letter announcing the rejected request, the FDA said its review of the new submission would likely take upwards of six months as its required onsite inspections of the China-based manufacturer have been hindered by travel restrictions related to the COVID-19 pandemic.
“We will continue to work closely with our partner, Junshi Biosciences, to facilitate the completion of the FDA’s review of the toripalimab (request),” Denny Lanfear, CEO of Coherus, said in a press release. “In late April, we responded quickly to an FDA request for a quality process change and implemented required actions. We plan to first meet with the FDA and directly thereafter to resubmit the (request). The FDA has indicated that the existing toripalimab clinical data are supportive of the submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions.”
Currently, according to the press release, there are no FDA-approved immunotherapy treatments for patients with nasopharyngeal carcinoma. Because of the location of the primary tumor, surgery is not often an option for patients. Moreover, localized disease is typically treated with radiation and chemotherapy.
In China, toripalimab is approved for use in:
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