GSK PLC on Monday reported a triple dose of good news with positive regulatory updates on two leading cancer drugs.

The London-based pharmaceuticals firm said jemperli, the brand name of dostarlimab, plus chemotherapy has received a positive opinion from the Committee for Medicinal Products for Human Use to expand approval to all adult patients with primary advanced or recurrent endometrial cancer.

The positive opinion is based on statistically significant and clinically meaningful progression-free and overall survival data from phase III Ruby trial.

An expanded approval would include patients with mismatch repair proficient/microsatellite stable tumours, who represent 70% to 75% of patients diagnosed with endometrial cancer and who have limited treatment options, GSK noted.

The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission, with an approval decision expected in the first quarter of 2025.  

In addition, GSK said jemperli has received US Food & Drug Administration Breakthrough Therapy Designation for locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.

The designation is based on data showing no evidence of disease in 100% of all 42 patients who completed treatment with jemperli.

The BTD is granted to drugs with potential to show improvement over available therapies for serious conditions.

This is the second regulatory designation for dostarlimab in locally advanced dMMR/MSI-H rectal cancer, following Fast Track designation for the same patient population in January 2023.

Further, GSK said its B7-H3-targeted antibody-drug conjugate, GSK’227, has received European Medicines Agency Priority Medicines Designation in relapsed extensive-stage small-cell lung cancer.

The Prime designation is based on promising preliminary clinical data.

Prime designation is granted to medicines with potential to address significant unmet medical needs, the firm noted.

This is the second regulatory designation for GSK’227, following the US FDA’s decision to grant Breakthrough Therapy Designation in August, GSK added.

Hesham Abdullah, senior vice president, Global Head Oncology, R&D, GSK, said: ‘This Prime Designation is an important step forward as we seek to accelerate development of GSK’227 in extensive-stage small-cell lung cancer and other tumour types with limited treatments. Our investigational B7-H3-targeted ADC is a key component of our broader ADC programme.’

Shares in GSK were 0.8% lower at 1,319.00 pence each in London on Monday morning.

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