Features / Comment / Insight / Analysis / Facts 
December 2023  Vol 25 Issue 10

CHMP shares positive opinion for GSK’s momelotinib for myelofibrosis treatment
GSK has announced that CHMP has given a positive recommendation to momelotinib for patients with myelofibrosis, page 4
New data shared for Leqembi as Alzheimer’s treatment
Eisai and Biogen have announced new data for Leqembi injection for IV use at the 16th Annual Clinical Trials on Alzheimer’s Disease, page 7
J&J plans to submit surgical robot to regulators in 2024
J&J has announced plans to submit the Ottava robotic surgical system to the FDA for an IDE application in the second half of 2024, page 10

AstraZeneca’s Truqap plus Faslodex approved by FDA for treatment of breast cancer

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) in combination with Faslodex (fullvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations.
The approva l was based on results from the CAPItello-291 phase 3 trial, with results having been published in The New England Journal of Medicine. The trial demonstrated that Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone.
The safety prof ile of the drug remained similar to that obser ved in previous trials.
The regulatory submission of the drug was granted Priority Review under Project Orbis, which provides a ‘framework for concurrent submission and review of oncolog y medicines among participating international partners,’ according to the company’s press release.
The drug is now under review by the relevant regulatory authorities in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK.
Dave Fredrickson, executive vice president of the Oncolog y Business Unit at AstraZeneca, commented: “The rapid US approva l of Truqap reinforces the important role of the PI3K/AKT pathway in HRpositive breast cancer and the critical need to test patients at the time of diagnosis, as up to 50% have tumours with these alterations. As a f irst-in-class medicine, this approva l provides a critical new option for patients in the US with this specific type of disease and we look forward to bringing Truqap to the many breast cancer patients who can benef it across the globe.”
Komal Jhaveri MD, medical oncologist at the Memorial Sloan Kettering Cancer Center (MSK), US, added: “Patients with advanced HR-positive breast cancer typically experience tumour progression or resistance with widely used firstline endocrine therapies and there is an urgent need to extend the effectiveness of these approaches. The combination of capivasertib and fulvestrant, a f irst-of-itsk ind combination, provides a much-needed new treatment option for up to half of patients in this setting with these specific biomarkers, offering the potential to delay disease progression and prov ide more time with their disease under control.”