FDA Greenlights AstraZeneca Truqap: In a significant development, the U.S. Food and Drug Administration (FDA) gave the green light to AstraZeneca’s (AZN.L) Truqap, combined with an older drug, offering a new avenue for treating the most prevalent form of breast cancer.
This FDA approval sanctions the use of capivasertib, the chemical identity of Truqap, alongside AstraZeneca’s established cancer treatment faslodex.
Truqap enters a competitive arena of breast cancer therapies, joining the ranks of AstraZeneca-Daiichi Sankyo’s Enhertu and Gilead’s (GILD.O) Trodelvy. The FDA specified that Truqap is suitable for adult patients with HR-positive/HER2-negative breast cancer. Moreover, the drug is approved for patients whose tumors exhibit alterations in one of three genes—PIK3CA, AKT1, or PTEN.
In a pivotal late-stage study, Truqap demonstrated a significant extension of the time patients with gene-altered tumors lived without disease progression— a noteworthy 7.3 months.
Belonging to the AKT inhibitors class, Truqap operates by targeting the AKT1 gene mutation responsible for tumor growth. The drug is applicable to patients whose tumors resurface or worsen post hormone-based therapy, as outlined by the health regulator.
While the FDA approval marks a crucial advancement, common side effects of Truqap include diarrhea, reduced hemoglobin, nausea, and fatigue, underscoring the importance of weighing potential benefits against these considerations.
Breast cancer stands as the most frequently diagnosed cancer among U.S. women, ranking second in cancer-related deaths for this demographic, according to the American Cancer Society. The nod from the FDA opens new possibilities in the ongoing battle against this prevalent and impactful disease.
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