GSK's Cancer Drug Jemperli Nears EU Marketing Expansion -- 2nd Update

By Christian Moess Laursen

GSK's cancer drug Jemperli cleared an important hurdle ahead of potentially expanding its European Union marketing permission, in a boost to the pharmaceutical giant's oncology pipeline.

The British company said Monday that the European Medicines Agency recommended expanding the approval of Jemperli used in combination with chemotherapy for treatment of adult patients with primary or recurrent endometrial cancer who are candidates for systemic therapy.

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium.

The drug is already approved in this setting for cancers with defective DNA mismatch repair systems that cause high levels of genetic instability, also called dMMR/MSI-H.

The recommendation sets the treatment up to be approved for use in combination with chemotherapy for all patients, regardless of subtype.

It is one of the final steps before a marketing authorization decision by the EMA. This decision is expected during the first quarter of next year.

The application to expand the use of Jemperli comes after it received a so-called positive opinion from the EMA's Committee for Medicinal Products for Human Use.

Endometrial cancer is the most common gynecologic cancer in developed countries, with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.

Meanwhile, the treatment was also designated a breakthrough therapy by the U.S. Food and Drug Administration, GSK said in a separate release. The designation, granted by the FDA to expedite development of drugs to intended to treat serious or life-threatening conditions, relates specifically to Jemperli used for the treatment of patients with a certain type of rectal cancer.

It was based on data that showed no evidence of disease in all of the 42 patients who completed treatment with Jemperli.

Write to Christian Moess Laursen at christian.moess@wsj.com

(END) Dow Jones Newswires

December 16, 2024 07:03 ET (12:03 GMT)

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