GSK plc’s GSK HIV subsidiary, ViiV Healthcare announced that the Europe Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending marketing authorization for its new long-acting HIV regimen.
ViiV Healthcare is a global specialist HIV company, majorly owned by GSK with Pfizer PFE and Shionogi as shareholders.
ViiV Healthcare was formed by GSK and Pfizer in 2009.
The CHMP recommended marketing authorization to Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s JNJ Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in virologically suppressed adolescents aged 12 years and above, weighing at least 35 kg.
A decision from the European Commission is expected in the upcoming months.
The EMA approved GSK’s Vocabria plus J&J’s Rekambys for the treatment of HIV-1 in adults who are virologically suppressed in December 2020.
Per management, if approved, the expanded indication for cabotegravir and rilpivirine long acting will mark the first time a complete, long-acting regimen which is available for adolescents living with HIV in Europe.
Year to date, shares of GSK have plunged 9.4% compared with the industry’s decline of 11.4%.
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Jemperli Gets CHMP Nod for Expanded Use
In another press release, GSK announced that the CHMP has recommended expanded use of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer.
Jemperli is presently approved in combination with carboplatin and paclitaxel as a frontline treatment for mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in adult patients who are candidates for systemic therapy.
The expanded use for Jemperli would include patients with mismatch repair proficient or microsatellite stable tumors, representing the majority of endometrial cancer cases having limited treatment options.
A final decision from the European Commission is expected in the first quarter of 2025.
GSK's Jemperli Gets FDA’s Breakthrough Therapy Tag
In a separate press release, GSK announced that the FDA has granted Breakthrough Therapy designation to Jemperli for the treatment of patients with locally advanced dMMR or MSI-H rectal cancer.
The FDA grants breakthrough therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
Jemperli is approved for second-line endometrial cancer and dMMR recurrent or advanced solid tumors in the United States. The drug was also approved to treat endometrial cancer in broader patient populations in August 2024.
Jemperli, a PD-1 inhibitor, was developed by GSK in collaboration with AnaptysBio ANAB.
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications. Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK's ADC Drug Gets EMA’s Priority Medicines Status
In a separate press release, GSK announced that the EMA has granted Priority Medicines (PRIME) designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed extensive-stage small-cell lung cancer (ES-SCLC).
The PRIME designation is granted by the EMA to support the development of medicines, which target an unmet need.
The FDA granted Breakthrough Therapy designation to GSK’227 for treating relapsed or refractory ES-SCLC in August.
GSK's Zacks Rank
GSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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