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US, Canada, Australia Simultaneously Approve Endometrial Cancer Combo

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The US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada (HC) today simultaneously approved a new two-drug combination for the treatment of advanced endometrial carcinoma.

The three agencies worked together under the umbrella of Project Orbis, a new FDA initiative that allows concurrent submission and review of oncology products among international partners.

“This is the first time that we have approved a drug with another country in collaboration,”

The approvals were granted to lenvatinib (Lenvima, Eisai) in combination with pembrolizumab (Keytruda, Merck) for the treatment of patients with advanced endometrial carcinoma. All three approvals were conditional and will require further evidence of efficacy.

More specifically, the approvals are for patients whose disease is not microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR), who experience disease progression following prior systemic therapy, and who are not candidates for curative surgery or radiotherapy.

Both drugs are indicated for use in multiple other cancers. Project Orbis is only for supplemental oncology approvals or approvals for new indications for previously approved therapies. It is not for new drug applications.

“We are pleased to be working alongside our Australian and Canadian colleagues to help make potentially life-changing treatments available to patients as quickly as possible while still ensuring the FDA’s high standards of safety and effectiveness,” said acting FDA Commissioner Ned Sharpless, MD.

The approvals were facilitated by new processes and tools at the FDA that helped to expedite review in the three countries, said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, in the statement. “These applications were approved three months prior to the FDA goal date.”

The lenvatinib-plus-pembrolizumab approvals are based on efficacy and safety results of a clinical trial of 94 patients with endometrial carcinoma tumors that were not MSI-H or dMMR. Investigators reported an objective response rate of 38.3%. Among the 36 patients who responded to therapy, 10 had a complete response, and 26 had a partial response. For 25 patients (69% of those who responded), the duration of response was >6 months.

Common side effects for patients in the clinical trial included fatigue, high blood pressure, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, and stomatitis, said the FDA. Additional side effects included vomiting, decreased weight, abdominal pain, headacheconstipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, hand-foot syndrome, dyspnea, cough, and rash.

The FDA said that it has been working collaboratively with other drug review agencies for more than a decade.

In 2004, the FDA’s Office of Hematology and Oncology Products started conducting confidential teleconferences with other regulatory agencies related to applications under review.

Currently, the agency holds a monthly teleconference with Australia’s TGA, the HC, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and Switzerland’s Swissmedic. Also, the FDA and China’s National Medical Products Administration have quarterly meetings to discuss non-product-specific regulatory issues.

-GDMeds, an India Pharmacy Service company
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