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Allarity Therapeutics Requests Type C Meeting With FDA

By Chris Wack

 

Allarity Therapeutics Inc. said Tuesday it has requested a type C meeting with the Food and Drug Administration to discuss potential clinical paths to support approval of dovitinib in view of the regulatory agency's recent Refusal to File letters for the company's new drug application and related pre-market approval application.

The clinical-stage pharmaceutical company said on Feb. 18 that the FDA had provided it with Refusal to File letters regarding the new drug application for dovitinib, and its accompanying pre-market approval application for the DRP-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma.

In its announcement, Allarity said it intends to seek guidance concerning information, data and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The company also said it anticipates that a new prospective clinical trial will be required to overcome the FDA's outstanding objections.

Allarity has now filed a formal request with the FDA for a type C meeting to further discuss potential clinical paths to support approval of dovitinib, together with its DRP-Dovitinib companion diagnostic, in view of the FDA's recent RTFs.

The type C meeting is typically scheduled within 75 days of FDA receipt of the written meeting request. The company anticipates providing a further update on the outcome of its FDA meeting and the future of the dovitinib program before the end of the third quarter of this year.

Allarity said that with clarification from the FDA following its requested type C meeting, it hopes to have a clinical path forward with the goal of refiling our NDA and PMA once additional clinical data are in hand.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

March 15, 2022 09:05 ET (13:05 GMT)

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