US regulator accepts GSK’s application to expand treatment of cancer drug

Pharmaceutical giant GSK has received a special recognition from the US Food and Drug Administration (FDA) for its bepirovirsen drug.

The Food and Drug Administration (FDA) has accepted GSK’s application to expand treatment of its cancer-fighting technology, Jemperli.

The treatment, Jemperli, will now be classed as being able to help all adult patients with primary advanced or recurrent endometrial cancer. It is used alongside chemotherapy.

Currently, it is FDA-approved to treat adult patients with primary advanced or recurrent endometrial cancer that matches FDA specifications.

If accepted, the bar for treatment using Jemperli would be lower i.e. it would include patients with mismatch repair proficient (MMRp) tumours.

GSK’s application to expand the treatment was supported by “statistically significant” and “clinically meaningful” data from clinical trials.

Jemperli plus chemotherapy has been shown to be the only immuno-oncology-based therapy to show such a significant survival benefit in endometrial cancer, GSK said.

Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide, according to research.

Rates are expected to rise by almost 40% between 2020 and 2040, according to the International Agency for Research on Cancer.

Last December, Jemperli plus chemotherapy was approved as the first and only frontline immuno-oncology treatment in the European Union for advanced or recurrent endometrial cancer.

“People living with this type of endometrial cancer typically experience disease progression and poor-long term outcomes with current standard of care.

With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey.

We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy,” Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said at the time.

GSK has only recently moved into the oncology space. It is “seeking to make transformative breakthroughs in immuno-oncology, focusing on “haematologic malignancies, gynaecologic cancers and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies.”