publication date: Feb. 28, 2020

FDA approved 11 new agents, 30 supplemental indications in cancer in 2019

By Alexandria Carolan

Last year, FDA approved 11 new drugs and biologics as well as 30 supplemental indications and four biosimilars, according to commentary by FDA officials published in Nature Reviews.

Notably, FDA approved two novel drugs through a new international collaboration, Project Orbis, which provides a framework for concurrent submission and review of oncology drugs by international partners—the first regulatory action of its kind. The United States, Australia, and Canada approved the drugs (The Cancer Letter, Sept. 20, 2019).

The authors are: Harpreet Singh, acting director of Division of Oncology 2, Gideon Blumenthal, then the acting supervisory associate director of the Office of Oncologic Diseases, and Richard Pazdur, director of the Oncology Center of Excellence.

“Future collaborations between international regulators could provide patients with earlier access to products in other countries in which substantial delays in regulatory submissions might occur,” Singh, Blumenthal, and Pazdur wrote.

In September, FDA, the Australian Therapeutic Goods Administration, and Health Canada granted simultaneous approval for the combination of pembrolizumab and lenvatinib for advanced-stage endometrial carcinoma that is not microsatellite-instability high or mismatch repair deficient, and who had disease progression following prior systemic therapy.

In November, regulators from the same countries approved acalabrutinib for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The authors also highlighted the approval of entrectinib, a small-molecule NTRK inhibitor that was the second site-agnostic biomarker-defined new molecular entity approved by FDA. Entrectinib is used to treat pediatric and adult patients with NTRK fusion-positive unresectable or metastatic solid tumors.

“In the main study … Continue reading FDA approved 11 new agents, 30 supplemental indications in cancer in 2019

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