FDA Approves New Cancer Treatments Amidst Rising Global Cancer Rates
核心洞察
The FDA issued 16 oncology approvals between July and September 2024, addressing the global surge in cancer (搜索) cases, particularly among individuals under 50.
Oncolytics Biotech is advancing pelareorep, with plans to submit a clinical trial for HR+/HER2- breast cancer (搜索) to the FDA in early 2025, following positive BRACELET-1 trial results.
AbbVie (搜索) has submitted a BLA for telisotuzumab vedotin for previously treated non-small cell lung cancer (搜索) (NSCLC) with c-Met (搜索) protein overexpression.
The FDA has approved 16 new cancer (搜索) treatments between July and September 2024, as global cancer rates continue to rise, especially among those under 50. New cases have increased by 79%, with the most rapid increases observed in windpipe and prostate cancers. The highest death rates are associated with cancers of the breast, windpipe, lung, bowel, and stomach. The United Nations projects a 77% increase in cancer rates by 2050. Biotech companies are actively developing new therapies to combat this surge.
Oncolytics Biotech Advances Pelareorep for Breast and Pancreatic Cancer
Oncolytics Biotech Inc. is making strides with its immunotherapeutic agent, pelareorep. Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer (搜索) are paving the way for a clinical study designed to support accelerated FDA approval. Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors, stated, "We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep."
The company plans to submit a clinical trial combining pelareorep with paclitaxel to the FDA in early 2025. This trial will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer (搜索) who have progressed on antibody-drug conjugates (ADCs) or are ineligible/intolerant to ADCs, representing about 55,000 patients in the US. The study is designed to deliver a p-value of < 0.05 with a progression-free survival (PFS) benefit of ≥4.3 months. The BRACELET-1 study demonstrated a 5.7-month benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone. Enrollment is expected to commence in the first half of 2025.
AbbVie Seeks Approval for Telisotuzumab Vedotin in NSCLC
AbbVie (搜索) has submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (搜索) (NSCLC) with c-Met (搜索) protein overexpression. Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie, noted, "Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis. We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology."
BeiGene's Tevimbra and PD-1 Inhibitor Class
BeiGene (搜索), Ltd. announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) recognized the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (搜索) (ESCC) expressing PD-L1 (搜索) (>1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 >1%. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene, stated, "The vote by ODAC members to recommend a class-level cut-off of PD-L1 expression for PD-1 inhibitors used in the treatment of gastric/GEJ cancers and ESCC will help to establish a standard for clinicians and the patients they treat."
HUTCHMED's Fruzaqla Approved in Japan
HUTCHMED (China) Limited announced that its partner Takeda received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (搜索) (CRC). Dr Weiguo Su, CEO and CSO of HUTCHMED, said, "Takeda has now obtained approval in Japan for FRUZAQLA®, demonstrating the strength of our global data package and the potential of this novel medicine to provide a much-needed treatment option to patients with metastatic CRC."
Enliven Therapeutics' ELVN-001 Shows Promise in CML
Enliven Therapeutics, Inc. announced positive data from the Phase 1 clinical trial evaluating ELVN-001, a potent, highly selective, potentially best-in-class small molecule kinase inhibitor, in patients with chronic myeloid leukemia (搜索) (CML) that has failed, or the patient is intolerant to or not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377).