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# Allarity Refocuses in Response to FDA Comments
- URL: https://www.fdaweb.com/allarity-refocuses-in-response-to-fda-comments/
- Published: 2022-08-02T12:00:00.000Z
- Updated: 2026-09-14T17:54:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152419

Allarity Therapeutics says its board has ordered a refocus of the company’s oncology drug pipeline away from monotherapies and toward combination drugs. One reason for the shift, it says, is information from a meeting with FDA on a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic renal cell carcinoma.

At the meeting, the company [says](https://investors.allarity.com/news/news-details/2022/Allarity-Therapeutics-Refocuses-Oncology-Pipeline-Strategy-Towards-Combination-Therapies/default.aspx?ref=fdaweb.com), FDA indicated Allarity would likely have to conduct a new dovitinib dosing study before doing any future Phase 3 studies that could enable the submission of a new NDA. “In view of these delays and increased costs/risks, the company has determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable…,” Allarity says.

The company says its board determined that the change in focus will:

- align with the ongoing shift in cancer therapy standard-of-care toward combination therapies;
- strengthen the company’s ability to attract additional funding;
- significantly broaden the company’s possibilities for future commercial partnering; and
- improve the likelihood of clinical and commercial success of the company’s pipeline assets.