News

A phase 1 trial of COM503 in metastatic or advanced solid tumors is expected to begin in Q4 2024.

The FDA has extended the PDUFA target action date for the new drug application of revumenib for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia to December 26, 2024.

The FDA granted priority review to asciminib for the treatment of newly diagnosed, Philadelphia chromosome-positive, chronic phase chronic myeloid leukemia.

The NCCN has updated its guidelines to recommend imetelstat as a top treatment for symptomatic anemia in lower-risk MDS, following its FDA approval based on encouraging phase 3 trial results.

Replacing fluorouracil with paclitaxel in combination with pembrolizumab and carboplatin appears to be efficacious and tolerable in patients with recurrent/metastatic head and neck cancer.

The combination of acalabrutinib and venetoclax with or without obinutuzumab improved survival vs standard chemotherapy in patients with previously untreated chronic lymphocytic leukemia.

The FDA approval of Guardant Shield marks the second blood-based diagnostic test for colorectal cancer in those age 45 and older at average risk of the disease.

The FDA cleared ADC, ZW191, for difficult-to-treat cancers, immunotherapy showed varied efficacy in angiosarcomas, and the cabozantinib/nivolumab combination demonstrated promising results in RCC. We also cover FDA setbacks for botensilimab/balstilimab in mCRC, and the lackluster effects of nivolumab/tivozanib for RCC.

A new dendritic cell vaccine has shown promising results in extending survival for pancreatic cancer patients by stimulating the immune system to fight tumor cells.

SenoVax, a novel senolytic immunotherapy for NSCLC, has been submitted as an investigational new drug application to the FDA, initiating a clinical trial to test its efficacy.

The CAR T-cell therapy UCART22 has been granted orphan drug designation and rare pediatric drug designation from the FDA for the treatment of acute lymphoblastic leukemia.

Findings from the phase 2 NeoPembrOV study supported the addition of pembrolizumab to neoadjuvant chemotherapy before surgery in high-grade serous ovarian cancer.

The FDA’s Oncologic Drugs Advisory Committee convened to assess the need for rigorous trial designs evaluating perioperative regimens in resectable non–small cell lung cancer.

A phase 2 trial shows that THIO, a new investigational drug, combined with cemiplimab, may be an effective and well-tolerated treatment for patients with advanced non–small cell lung cancer who have exhausted other options.

Patients treated with hormone-modulating therapy for breast cancer had a reduced risk of developing Alzheimer disease or dementia compared with patients treated with other agents.

Matthew Hadfield, DO, discusses his interest in immunotherapy and the toxicities associated with them.

The first pretreated patient with HER2-altered non–small cell lung cancer was dosed with NVL-330, a novel HER2-selective inhibitor, in the HEROEX-1 trial.

Bhavana Pothuri, MD, discussed the importance of testing and accessing treatment for patients with endometrial cancer.

The FDA has granted a fast track designation to ozuriftamab vedotin for treating recurrent/metastatic head and neck cancer that progressed after prior therapies.

TLX007-CDx, if approved by the FDA, has the potential to become a new PSMA PET imaging agent for prostate cancer.

Laura Huppert, MD, discussed a retrospective study exploring the sequential use of antibody-drug conjugates for the treatment of HER2-low metastatic breast cancer.

The FDA has accepted the resubmitted application of remestemcel-L, a potential first-of-its-kind treatment for pediatric patients following stem cell transplants.

The tyrosine kinase inhibitor entrectinib shows promising responses in patients with non–small cell lung cancer harboring a ROS1 mutation.

The FDA has approved an individual patient investigational new drug application, allowing for a second dose of a novel CAR T-cell therapy for a patient with recurrent ovarian cancer.

AIC100 now has a regenerative medicine advanced therapy designation from the FDA for the treatment of recurrent anaplastic thyroid cancer.

An analysis from the innovaTV 301 showed that tisotumab vedotin in the second- and third-line bettered overall survival vs investigator’s choice of chemotherapy in patients with cervical cancer.

Clinical development of ZW191 is planned to begin in the second half of 2024.

Amivantamab/lazertinib trumps osimertinib in lung cancer treatment, promising results with nivolumab in dMMR in gynecologic cancers, and Curium’s lutetium-177 submission for SSTR-positive GEP-NETs are featured. Regarding lung cancer, we also cover valuable insights on immunotherapy combinations and breakthrough treatments presented at ASCO.

Taiga Nishihori, MD, discusses a study in which investigators evaluated patients with relapsed/refractory multiple myeloma who were hospitalized and treated with commercial ciltacabtagene autoleucel at Moffitt Cancer Center between May 2022 and May 2023.