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March 08, 2019 – FDA Approvals, News & Updates

Web Exclusives - FDA Approvals, News & Updates, In the News

Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.

In This Article


FDA Approves Lonsurf (trifluridine/tipiracil) for Recurrent, Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

On February 22, 2019, the US Food and Drug Administration (FDA) approved Lonsurf (trifluridine/tipiracil, also known as TAS-102) tablets (Lonsurf; Taiho), for adults with metastatic gastric cancer (mGC) or gastroesophageal junction (GEJ) adenocarcinoma who had previously been treated with 2 lines of chemotherapy.

This is a supplemental indication for Lonsurf, which had obtained FDA approval in 2015 for use in the treatment of metastatic colorectal cancer.

The FDA, following its policy of expediting the review of drugs used for serious conditions and those that would provide a significant improvement in safety or effectiveness, granted the manufacturer’s application a priority review.

Gastric cancer is the 15th most common cancer in the United States. In 2018, there were an estimated 26,240 new cases of gastric cancer diagnosed, and 10,800 deaths attributed to the disease. Approximately 35% percent of US patients with gastric cancer are diagnosed at the distant or metastasized stage. mGC and GEJ are associated with 5-year survival rates of approximately 5%.

Patients living with mGC or GEJ adenocarcinoma have limited effective treatment options after standard treatment options have failed. “The approval of Lonsurf represents a significant milestone,” said Timothy Whitten, President and Chief Executive Officer of Taiho Oncology, in a company press release.

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Additional Method of Administration Approved for Cinvanti in Chemotherapy-Induced Nausea and Vomiting

On February 27, 2019, the FDA also approved a new method of administration for the antiemetic Cinvanti (aprepitant) manufactured by Heron Therapeutics. Cinvanti is used, in combination with other antiemetics, to reduce chemotherapy-induced nausea and vomiting, a common side effect in patients with cancer.

Previously, Cinvanti has been administered by intravenous infusion which takes 30 minutes; the new method, a push injection, allows it to be administered in 2 minutes, which will reduce the patient’s overall time spent in the infusion suite.

The FDA approval is based on results of a 2-part, phase 1 study and was granted under a supplemental new drug application (sNDA). A manufacturer must submit an sNDA when it wishes to change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug. The FDA previously approved Cinvanti as a 30-minute IV infusion in November 2017, when it became the first and only polysorbate 80-free IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.

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FDA Grants Approval to New Formulation of Herceptin

On February 28, 2019, the Food and Drug Administration approved the combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase-oysk, an endoglycosidase (Herceptin Hylecta; Genentech Inc.) for subcutaneous use for the treatment of HER2 overexpressing breast cancer.

The new formulation combines the monoclonal antibody trastuzumab with the recombinant enzyme human hyaluronidase PH20 which allows it to be injected under the skin. The benefit of the new formulation is that IV trastuzumab takes 30 to 90 minutes to administer, whereas this ready-to-use injectable formulation can be administered in 2 to 5 minutes and in fewer cycles.

The approval for the subcutaneous formulation is based on data from 2 large clinical trials in patients with HER2-positive early breast cancer: HannaH and SafeHER. The injectable formulation of Herceptin was approved in 2013 in Europe, and is available globally, however approval in the US lagged. It was finally cleared under the FDA’s new Biologics License Application.

Breast cancer is the most common female cancer worldwide, and trastuzumab is considered an essential drug in fighting the disease.

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Last modified: March 11, 2019