Foresee Pharmaceuticals announced on the 29th that its prostate cancer drug CAMCEVI 3-month formulation has entered the substantive review phase for the U.S. New Drug Application (NDA). Once approved, it will become another treatment option in the prostate cancer market, following the approval of the CAMCEVI six-month formulation.
The company stated that on October 29, 2024, it completed the submission of the NDA for CAMCEVI 3-month formulation (leuprolide mesylate), a three-month sustained-release injectable, to the U.S. Food and Drug Administration (FDA). On November 1, the FDA informed the company that if no notice of incomplete application is received within 60 days of submission, the application will enter substantive review on December 28, 2024. As of December 27, the company had not received any notice of incomplete application, thus moving the case into substantive review.
The approval timeline depends on the FDA’s review and decisions. The Prescription Drug User Fee Act (PDUFA) review goal date will be based on the FDA’s Day 74 letter, but the final approval time and outcome are at the FDA’s discretion.
Foresee stated that with the aging population, the number of prostate cancer patients is increasing. According to the global cancer database GLOBOCAN, prostate cancer is the second most common cancer among men worldwide. In 2022, 14.2% of the approximately 10 million new cancer cases in men were prostate cancer. Additionally, according to Nova One Advisor, the global prostate cancer therapeutics market was valued at approximately $16.46 billion in 2022 and is projected to grow to $36.54 billion by 2032, with a compound annual growth rate (CAGR) of 8.3%. The market for hormone therapies related to CAMCEVI is also substantial.
According to Precision Reports, the global leuprolide market was valued at approximately $2.455 billion in 2021 (across all indications), and it is expected to reach $3.264 billion by 2027, with a CAGR of about 4.86%.
CAMCEVI 21 mg is developed using an exclusive sustained-release injection platform technology, improving on the longstanding challenges of manual mixing required for high-activity leuprolide injections, addressing inconvenience and potential usage issues that have existed for the past 30 years.
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