Leuprolide Injection Emulsion Now Available in the US for the Treatment of Advanced Prostate Cancer

Granted approval by the FDA on May 25, 2021, leuprolide (Camcevi) 42 mg injection emulsion for the treatment of adult patients with advanced prostate cancer has launched in the United States (US). This news was announced by Accord BioPharma, who is partnered with Foresee Pharmaceuticals Co., Ltd.¹

"The US launch of Camcevi validates the importance of Foresee's pioneering Stabilized Injectable Formulation (SIF) technology and is a monumental step toward fulfilling our mission of improving on a standard of care," said Dr. Ben Chien, founder and chairman of Foresee, in a statement. "We know that Accord BioPharma shares in that important goal."

The 6-month subcutaneous depot formulation of leuprolide mesylate was approved by the FDA based on a phase 3 study that was conducted in a total of 137 patients with advanced prostate cancer who received the formulation via a 42-mg injection, every 6 months. The open-label, multicenter phase 3 trial sought to determine the safety, efficacy, and pharmacokinetic profile of the agent at 50 mg for up to 1 year of treatment of treatment in patients with advanced prostate cancer.

The primary end point of the trial was suppression of serum testosterone (≤ 50 ng/dL) by day 28, and from day 28 to day 336 in the intent-to-treat population.

Results from the study showed that 97% of patients achieved serum testosterone suppression ≤ 50 ng/dL in the prespecified amount of time. The mean testosterone concentration was suppressed below castrate levels to 17.6 ng/dL by day 28.

Leuprolide is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection. It comes in a pre-filled syringe requiring no mixing. In an open-label, single-arm study, 137 patients received 42 mg of leuprolide on Day 0 and Week 24. Leuprolide offered consistent testosterone suppression to castrate levels after the initial injection from Week 4 to Week 48. It is noted that patients with hypersensitivity to GnRH or GnRH analogs should take or use Camcevi as it can lead to possible anaphylactic reactions.³ Occurring within the medium follow up of 336 days, the most common adverse reactions (≥ 10%) were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

"Foresee's technology allows us to offer a therapy for advanced prostate cancer that is both effective and convenient for practitioners, with the pre-filled syringe providing simplified preparation that leads to an improved treatment experience for healthcare professionals," said Chrys Kokino, president of US BioPharma at Accord BioPharma, in the press release. "Camcevi marks an important example of our philosophy – going beyond biology – in action."

_References

_{1. Accord biopharma, in partnership with foresee pharmaceuticals, launches CAMCEVI™ (Leuprolide) injection emulsion in the U.S. for the treatment of advanced prostate cancer in adults. Press release. Yahoo Finance. April 4, 2022. Accessed April 6, 2022. https://yhoo.it/3x4h1jP}

_{2. Foresee Pharmaceuticals announces FDA approval of CAMCEVI for the treatment of advanced prostate cancer; Accord BioPharma to head the US commercialization. News release. Foresee Pharmaceuticals. May 26, 2021. Accessed April 6, 2022. https://prn.to/3LMV6So}

_{3. CAMCEVI. Prescribing Information. Accord BioPharma; May 2021. Accessed April 6, 2022.}