SFDA Approves Camizestrant to Advance 1st-Line therapy Options for Patients with Advanced Breast Cancer in Saudi Arabia

Riyadh - AstraZeneca is pleased to announce that the Saudi Food and Drug Authority (SFDA) has approved Etcamah (camizestrant), providing a new treatment option for patients with hormone receptor (HR) positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation that emerges during first-line hormonal therapy, in combination with CDK4/6 inhibitors.

This is among the first approvals of Camizestrant globally, and the first global approval by a maturity level 4 regulatory body, underscoring Saudi Arabia´s growing leadership in enabling rapid access to next generation therapies.

Camizestrant is an oral selective estrogen receptor degrader (SERD) and complete estrogen receptor antagonist. It is designed to target and degrade estrogen receptors that drive the growth of breast cancer cells.

This approval was based on data from the Phase III SERENA-6 clinical trial, which evaluated camizestrant in combination with a CDK4/6 inhibitor in patients with HR-positive, HER2-negative advanced breast cancer following the detection of a genetic mutation during treatment. The study included a comparison between switching to camizestrant and continuing standard endocrine therapy in combination with a CDK4/6 inhibitor, with progression-free survival assessed as one of the trial’s primary endpoints.

Breast cancer remains the most commonly diagnosed cancer in Saudi Arabia, accounting for around 20% of all new cancer cases, with more than 4,100 cases reported in 2023. This approval reflects the SFDA’s commitment to accelerating patient access to innovative medicines through its Breakthrough Medicine Program and reinforces Saudi Arabia’s growing role in advancing healthcare innovation and expanding access to new therapeutic options.

Dr. Meteb Al Foheidi, Consultant Oncologist and President of the Saudi Oncology Society, said:“This approval by the Saudi Food and Drug Authority (SFDA) represents an important scientific advancement in the management of HR-positive, HER2-negative advanced breast cancer. Endocrine resistance remains a major clinical challenge, and the availability of a next-generation oral selective estrogen receptor degrader (SERD) provides a valuable new treatment option supported by robust clinical evidence. This milestone reinforces the shift toward biomarker-driven, personalized treatment strategies and expands our ability to optimize treatment selection, ultimately improving outcomes for patients across Saudi Arabia”

Hatem Werdany, Saudi Arabia Country President at AstraZeneca, said: “Despite advances in treatment, many patients with HR-positive breast cancer eventually experience disease progression. Innovations such as Etcamah have the potential to treat emerging resistance before disease progression. This approval is an important step in expanding treatment options for patients in Saudi Arabia."

AstraZeneca remains committed to collaborating with partners across the healthcare system in Saudi Arabia to advance earlier detection and deliver scientific advancements that improve patient outcomes.

Etcamah should be used in accordance with the SFDA-approved prescribing information. Please consult a healthcare professional for full safety and prescribing details.