Source: Foresee Pharmaceuticals Co. Ltd.
Foresee Pharmaceuticals, (“Foresee”) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer.
“The approval of CAMCEVI® 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients,” said Dr. Ben Chien, founder and Chairman of Foresee. “It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.
The FDA approval was based on a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI® 42 mg injection every 6 months was demonstrated to be effective, safe and well tolerated (most common adverse events listed below in ISI). The primary efficacy end point was the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.
CAMCEVI® 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization. “Camcevi® 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer,” Said Chrys Kokino, U.S. President Accord BioPharma specialty products.
Important Safety Information for the U.S.
CAMCEVI® 42 mg subcutaneous injection is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI® is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of CAMCEVI®.
Patients may develop tumor flare during the first few weeks of treatment, which is a transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer. Monitor patients closely and manage symptoms.
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.
Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice.
Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes.
Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI®. Patients experiencing convulsions should be managed according to the current clinical practice.
Based on findings in animal studies and mechanism of action, CAMCEVI® may cause fetal harm.
The most common (≥10%) adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
Please see the full prescribing information for CAMCEVI® 42 mg for more information.
About Foresee Pharmaceuticals Co. Ltd.
Foresee is a Taiwan and U.S.-based biopharmaceutical company listed on the Taipei Exchange. Foresee’s R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.
Foresee's product portfolio includes late stage and early stage programs. CAMCEVI® 42 mg is now approved in the U.S. and under regulatory review in the EU. Additionally, U.S. and EU regulatory submissions are in preparation for CAMCEVI® 21 mg. Foresee is in clinical stage development of FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. FP-025 is currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). Foresee is also developing FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia, and FP-004, a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain.
About Accord BioPharma
Accord BioPharma is the U.S. specialty division of India-based Intas Pharmaceuticals, Ltd., one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. The Company is known for its range of products in three important therapeutic areas, oncology, immunology and critical care. Accord BioPharma is developing an exciting portfolio of specialty, complex molecules and biosimilar products. It is committed to improving patient access as well as providing affordable treatment options.