US FDA grants accelerated approval to AstraZeneca breast cancer drug Etcamah

…with breast cancer who have a specific mutation that can develop during treatment with an endocrine therapy. Patients will need to have an FDA-authorised test showing they have this mutation before receiving Etcamah. " Approval [was] based on SERENA-6 Phase III trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation, " AstraZeneca said. Dosage: ETCAMAH is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally, once daily. The recommended dose of ETCAMAH in…

…combination with a CDK4/6 inhibitor is 75 mg, AstraZeneca said. Etcamah can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the use of cancer medicines. “ Etcamah is available as tablets to be taken by mouth once a day. Treatment should continue for as long as the patient benefits from it, or until they develop unacceptable side effects, ” says the European Medicines Agency. High risk: The drug poses a high risk to pregnant women. "Based on findings in animals and the mechanism of action, ETCAMAH can cause fetal harm when administered to a pregnant…

…women with breast cancer an additional way to treat the disease. Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical Oncology, Winship Cancer Institute of Emory University and investigator for the trial, said: “ The combination provides an important new option for the one in three patients with this form of advanced breast cancer whose tumors develop ESR1 mutations before clinical or radiographic disease progression. " "Today’s approval will enable clinicians to promptly intervene and change therapeutic strategy at an earlier opportunity ahead of disease progression, rather than waiting until the cancer becomes harder to treat, and…