Europe's CHMP gives thumbs up to AZ's breast cancer drug after thumbs down from FDA adcomm
Less than a month after an FDA advisory committee voted 6-3 to reject AstraZeneca’s camizestrant, Europe’s Committee for Medicinal Products for Human Use (CHMP) has blessed it with a positive opinion.The European experts have recommended that the oral SERD treatment can be used in combination with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer if they have ESRI mutations.
Regulatory Divergence: FDA vs. Europe
Last month, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised questions about the design of the pivotal SERENA-6 study, which showed a 56% improvement in progression-free survival (PFS) for switching to camizestrant, used on top of a CDK4/6 inhibitor, compared with continuing treatment with an aromatase inhibitor (AI) and a CDK4/6 drug.The FDA took issue with AZ’s study, arguing it did not address whether this first-line switch approach provides long-term benefit to patients compared with the standard practice of waiting until disease progression to use a new therapy.
Although camizestrant extended median PFS by 6.8 months in the trial design, the FDA was unsure of its clinical meaningfulness.The FDA has not yet issued its decision on the drug, though it usually sides with the recommendations provided by their expert committees.In Europe, the drug will carry the brand name Etcamah.
How Camizestrant Works
Camizestrant is an investigational, next-generation oral Selective Estrogen Receptor Degrader (SERD) being developed by AstraZeneca.Designed to treat Hormone Receptor-positive (HR+), HER2-negative breast cancer, it works by actively blocking estrogen and destroying estrogen receptors to delay cancer growth and combat treatment resistance.
Mechanism: It acts as a complete estrogen receptor antagonist with no agonistic (estrogen-like) effects.It induces the degradation of the estrogen receptor alpha (ER alpha) protein within the cell.
Overcoming Resistance: It is highly effective at neutralizing tumors with the ESR1 gene mutation, which is a primary driver of resistance to standard first-line therapies (like aromatase inhibitors).
