The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended AstraZeneca’s Truqap, along with Faslodex, for approval in the European Union.
Truqap is a potent adenosine triphosphate-competitive inhibitor of all three AKT [Ak strain-transforming] isoforms (AKT1/2/3).
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The Faslodex endocrine therapy is indicated to treat oestrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women.
CHMP’s recommendation is intended for the treatment of adult patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with specific alterations, following endocrine-based regimen failure.
Its positive opinion draws from the CAPItello-291 Phase III trial results, which demonstrated a 50% reduction in the risk of disease progression or death when Truqap was combined with Faslodex, compared to Faslodex alone.
Median progression-free survival improved from 3.1 to 7.3 months with the combination therapy.
The safety profile of the combination therapy was found to be consistent with previous trials.
Regulatory reviews are ongoing in countries including China, with approvals already in place in Japan, the US and other regions based on the CAPItello-291 trial outcomes.
AstraZeneca oncology research and development executive vice-president Susan Galbraith stated: “Today’s news re-inforces the practice-changing potential of Truqap in combination with Faslodex to extend the effectiveness of endocrine-based treatment approaches for patients who experience tumour progression on, or resistance to, widely used endocrine-based therapies.
“This recommendation recognises the high unmet need in this biomarker-specific patient population, and if approved, patients in Europe with this specific type of disease may be able to benefit from this first-in-class treatment option.”
AstraZeneca, which manufactures the Covishield vaccine for Covid-19, has admitted that the injection has potential side effects.
The Business Standard has reported that in a legal document before the High Court of Justice in London, UK, the company stated that the vaccine for Covid-19 could cause thrombosis with thrombocytopenia syndrome in extremely rare cases.
