Oncolytics and others advance cancer therapies as the FDA approves 16 new oncology treatments in 2024
A global surge in cancer among patients under 50 has led to a 79 percent rise in new cases, with windpipe and prostate cancers experiencing the fastest increases.
The highest death tolls are linked to cancers of the breast, windpipe, lung, bowel, and stomach. According to the United Nations, cancer rates are projected to increase by 77 percent by 2050.
In response, researchers are making significant progress with new therapies, while the US Food and Drug Administration (FDA) issued 16 oncology approvals between July and September 2024.
Biotech companies such as Oncolytics Biotech Inc., AbbVie, BeiGene, HUTCHMED, and Enliven Therapeutics have recently shared market updates highlighting their advancements.
Spherical Insights analysts project that the global oncology drug market will grow at a compound annual growth rate (CAGR) of 11.5 percent, reaching US$564.50bn by 2033. Additionally, the Global AI in Oncology Market is expanding rapidly, with an expected 35 percent CAGR toward US$13.6bn by 2032.
Oncolytics Biotech Inc. has announced key progress in its studies for breast and pancreatic cancer treatments using its immunotherapeutic agent, pelareorep.
Positive clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer have set the stage for an FDA-accelerated approval process. The company plans to submit a clinical trial combining pelareorep with paclitaxel to the FDA in early 2025.
This trial will involve approximately 180 patients with HR+/HER2- advanced or metastatic breast cancer, representing a patient population of about 55,000 in the US.
Wayne Pisano, interim CEO, and chair of Oncolytics' Board of Directors, expressed, “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.”
Oncolytics plans to initiate a registrational study for pelareorep combined with paclitaxel in the first half of 2025. The company also expects key milestones, including safety run-in data from its GOBLET study on pancreatic cancer, as well as updated efficacy data from a trial focused on anal cancer.
By the second half of 2025, initial efficacy results from the pancreatic cancer cohort of the GOBLET study are anticipated.
Other companies also made industry headlines. AbbVie submitted a Biologics License Application for telisotuzumab vedotin for non-small cell lung cancer (NSCLC), while BeiGene announced the FDA's Oncologic Drugs Advisory Committee recognized PD-1 inhibitors' benefit-risk profile for specific cancers.
HUTCHMED’s partner, Takeda, received approval to manufacture and market FRUZAQLA for metastatic colorectal cancer in Japan. Lastly, Enliven Therapeutics shared positive Phase 1 trial data for ELVN-001, a treatment for chronic myeloid leukemia.
