FDA Reviewing Amgen's Lumakras for Colorectal Cancer and Other Key Drug Applications
核心洞察
The FDA is expected to decide on Amgen's Lumakras in combination with Vectibix for metastatic colorectal cancer (搜索) by October 17, following positive Phase III results.
Camurus (搜索) seeks approval for a once-monthly subcutaneous octreotide injection (CAM2029) for acromegaly (搜索), offering improved convenience over existing treatments, with a decision by October 21.
Iterum Therapeutics (搜索) awaits the FDA's decision on oral sulopenem for uncomplicated urinary tract infections in women, backed by positive Phase III REASSURE study results by October 25.
Amgen is awaiting an FDA decision by October 17 regarding the approval of Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of metastatic colorectal cancer (搜索). This application is supported by the CodeBreaK 300 study, which enrolled 160 patients with the KRAS (搜索) G12C mutation.
Lumakras for Colorectal Cancer
The CodeBreaK 300 study demonstrated a significant improvement in progression-free survival compared to the investigator's choice of therapy. Data presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting also showed a trend toward better overall survival in patients treated with the Lumakras combination. Lumakras is a small molecule inhibitor designed to keep mutated KRAS (搜索) in an inactive state, preventing unchecked tumor growth and promoting cell death. While Lumakras received accelerated approval for non-small cell lung cancer in May 2021, full approval was denied in December 2023, necessitating an additional confirmatory study.
Camurus' Octreotide for Acromegaly
Camurus (搜索), a Swedish biotech, is seeking approval for its investigational subcutaneous injection of octreotide for the once-monthly treatment of acromegaly (搜索), a hormonal disorder characterized by abnormal bone and tissue growth. The FDA is expected to release its decision by October 21. Octreotide, a peptide drug, mimics the effects of somatostatin, inhibiting hormones like glucagon and insulin and blocking growth hormone action. Camurus' formulation, CAM2029, allows for better drug exposure and a more convenient once-monthly dosing schedule compared to the thrice-daily Bynfezia. The Phase III ACROINNOVA 2 study, involving 135 patients, demonstrated that CAM2029 led to better biochemical control of acromegaly, improvements in symptom burden, and enhanced quality of life compared to standard of care.
Iterum's Oral Sulopenem for UTIs
The FDA is reviewing Iterum Therapeutics (搜索)’ New Drug Application (NDA) for sulopenem etzadroxil/probenecid, known as oral sulopenem, for treating uncomplicated urinary tract infections (uUTI) in women, with a decision expected by October 25. The application is supported by the Phase III REASSURE study, which showed that oral sulopenem matched oral Augmentin (amoxicillin/clavulanate) in overall response, the study’s primary endpoint. Overall success, considering clinical and microbiological outcomes, was statistically better in the oral sulopenem group. The FDA's Antimicrobial Drugs Advisory Committee recently discussed Iterum’s application, with CEO Corey Fishman noting the discussion was encouraging for oral sulopenem’s regulatory prospects, as experts acknowledged it as an important treatment option for certain patients with uUTI.
Lexicon's Zynquista for Type 1 Diabetes and CKD
Lexicon Pharmaceuticals’ Zynquista (sotagliflozin) will be reviewed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on October 31 as an adjunctive therapy to insulin for controlling blood glucose levels in patients with type 1 diabetes (搜索) and chronic kidney disease (搜索) (CKD). Sotagliflozin inhibits the SGLT2 (搜索) and SGLT1 (搜索) proteins, involved in glucose absorption in the kidneys and gastrointestinal tract. Lexicon initially sought approval in 2018, backed by the inTandem clinical program involving three Phase III trials with approximately 3,000 patients. However, in January 2019, the EMDAC was split on its approvability due to concerns about diabetic ketoacidosis and other safety issues, leading to an FDA rejection in March 2019. Lexicon has since refiled its NDA, expressing confidence in the benefit/risk profile of sotagliflozin for type 1 diabetes and CKD.