FDA Approves IND for AS1986NS, a New Approach in Prostate …
Nov 15, 2024 · The investigational new drug (IND) application for AS1986NS, a novel prostate cancer diagnostic and treatment agent, has received FDA approval.
Perioperative Pembrolizumab Betters Survival in Stage III/IV Head …
Oct 8, 2024 · Perioperative pembrolizumab (Keytruda) led to improved event-free survival (EFS) in patients with stage III or IVA, resected head and neck squamous cell carcinoma (HNSCC), meeting the primary end point of the phase 3 KEYNOTE-689 study (NCT03765918). 1 “These results are substantial, as KEYNOTE-689 marks the first positive trial in 2 decades for patients with resected, locally advanced head ...
FDA OKs Study of Amezalpat in Frontline Liver Cancer
Nov 13, 2024 · The clinical and regulatory team at Tempest are thrilled to receive this notice from FDA with respect to the planned pivotal phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer,” said Sam Whiting MD, PhD, chief medical officer and head of research and development of Tempest, in a press release. 1 “Previously reported positive phase 2 data underscore ...
September 2024 FDA Roundup: Key Decisions Drive Oncology …
Oct 2, 2024 · FDA Grants Fast Track Designation to ICT01 Plus Azacitidine and Venetoclax in AML. ICT01, a humanized anti-BTN3A monoclonal antibody, plus azacitidine and venetoclax (Venclexta) earned fast track designation for the treatment of acute myeloid leukemia in patients 75 or older or those who have comorbidities that preclude standard induction chemotherapy on …
Multidisciplinary Approach to Thyroid Cancer Management
Nov 19, 2024 · Noah S. Kalman, MD, MBA, a radiation oncologist specializing in the treatment of gynecologic, head and neck, thoracic, and pediatric cancers at Miami Cancer Institute of Baptist Health Medical Group, discusses how oncologists can determine the best course of action for the treatment and management of a patient with thyroid cancer.
Belantamab Mafodotin Triplet Boosts OS Over Daratumumab …
Nov 16, 2024 · The combination of belantamab mafodotin-blmf (Blenrep) with bortezomib (Velcade) and dexamethasone elicited a statistically significant and clinically meaningful reduction in the risk of death vs daratumumab (Darzalex) combined with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma, according to findings from the phase 3 DREAMM-7 trial ...
Lenvatinib/Pembrolizumab Combo Shows Promise in Thymic …
Sep 13, 2024 · Treatment with lenvatinib (Lenvima) plus pembrolizumab (Keytruda) demonstrated a 5-month progression-free survival (PFS) rate of almost 90% in patients with platinum refractory advanced B3-thymoma and thymic carcinoma without autoimmune disorders, according to data from the phase 2 single-arm PECATI trial (NCT04710628) presented at ESMO Congress 2024. 1
Antibody-Drug Conjugates Show Unique Advantage in Breast …
Nov 19, 2024 · Erika P. Hamilton, MD, director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute, discusses antibody-drug conjugates (ADCs) in multiple types of breast cancer, and when to use these drugs in sequence.
HER2-Low and -Ultralow Populations Benefit from T-DXd in HR
Nov 13, 2024 · Targeted Oncology: Do you consider this patient with metastatic breast cancer (mBC) to be eligible for sacituzumab govitecan (Trodelvy)? Aditya Bardia, MD, MPH , FASCO: If you look at the label of sacituzumab govitecan, it says 2 prior lines of systemic therapy; it does not say which kind, so you can make a case that the endocrine-based treatment was also systemic therapy. 1 But the TROPiCS-02 ...
Tremelimumab Plus Durvalumab Turns Heads With Updated Five …
Sep 16, 2024 · Updated 5-year data from the phase 3 HIMALAYA study (NCT03298451) showed that the combination of single tremelimumab (Imjudo) with a regular interval of durvalumab (Imfinzi) elicited improved overall survival (OS) across multiple evaluations, including disease control and depth of response, in patients with unresectable hepatocellular carcinoma (uHCC).