Nichole Tucker

In PIVOT IO-001, patients with metastatic melanoma are no longer being enrolled and treatment arms have been unblinded after the combination of bempegaldesleukin and nivolumab did not meet its coprimary end points.

An update from the phase 2 AMEERA-3 clinical trial shows that amcenestrant does not improve progression-free survival in ER-positive, HER2-negative breast cancer.

The first patient has received PY314 in a phase 1b study, and patients with advanced solid tumor are being actively recruited as sites across the United States.

FDA approval has been granted to adjuvant olaparib for the treatment of BRCA-mutated, HER2-negative breast cancer.

Showing similarity to results from CheckMate 214, findings from CheckMate 920 shows that nivolumab plus ipilimumab can safety be administered to patients with non-clear cell renal cell carcinoma.

Following positive early results from the ASPEN-01 clinical trial, the first patient with HER2-positve gastric or gastroesophageal cancer has received the experimental combination of evorpacept, trastuzumab, ramucirumab, and paclitaxel in ASPEN-06.

A supplemental new drug application seeking FDA approval for darolutamide and docetaxel for the treatment of patient with metastatic hormone-sensitive prostate cancer has been submitted.

Epcoritamab had been granted orphan drug designation by the FDA for the treatment of follicular lymphoma and is being studied in a phase 1/2 clinical trial.

A partial clinical hold has been placed the NEON-2 trial by the FDA due to a concern with the safety of davoceticept used in combination with pembrolizumab to treat patients with advanced solid tumors.

The FDA has granted priority review to ivosidenib tablets as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia.

Dosing has begun in patients with advanced non–small cell lung cancer in the phase 1/2 Acclaim-1 clinical trial of quaratusugene ozeplasmid in combination with osimertinib after disease progression on osimertinib alone.

In an interview with Targeted Oncology, Tanya Dorff, MD, discussed the exploration of chimeric antigen receptor T-cell therapy in prostate cancer, including recent findings from a phase 1 clinical trial.

In the phase 3 monarchE clinical trial, long-term follow-up results show that the benefit of abemaciclib plus endocrine therapy continued beyond 2 years.

Nivolumab in combination with platinum-doublet chemotherapy has been granted FDA approval as neoadjuvant treatment for adult patients with resectable non-small cell lung cancer.

The FDA will now make a decision on the approval application for ublituximab/umbralisib in chronic lymphocytic leukemia and small lymphocytic lymphoma in June following an ODAC meeting.

In an interview, Jesus Berdeja, MD, discussed the introduction of ciltacabtagene autoleucel into the treatment landscape for relapsed/refractory multiple myeloma, how it may differ from idecabtagene vicleucel, and the future of CAR T-cell use in the space.

TJ-CD4B had been granted orphan drug designation by the FDA for the treatment of patients with gastric cancer, including gastroesophageal junction carcinoma.

The FDA has granted fast track designation to HPN217, for the treatment of patients with relapsed or refractory multiple myeloma, which is being evaluated in a phase 1/2 clinical trial.

In an interview with Targeted Oncology, John Mascarenhas, MD, discussed the introduction of pacritinib to the treatment landscape for myelofibrosis and severe thrombocytopenia, and the research supporting the recent FDA approval.

In an interview with Targeted Oncology™, Samuel K. Klempner, MD, discussed the promise of DKN-01 and early results from the DisTinGuish trial.

Pending a safety investigation by the developer and further information about risk to patients, the phase 1b trial of CYAD-101 in patients with metastatic colorectal cancer, has been placed on a partial clinical hold by the FDA.

Ciltacabtagene autoleucel had been granted FDA approval for the treatment of select patients with relapsed or refractory multiple myeloma.

The supplemental new drug application for ibrutinib as a potential treatment for pediatric chronic graft-versus-host disease is supported with findings from the phase 1/2 IMAGINE study.

The FDA will conduct a speedy review of the supplemental biologics license application filed for nivolumab in combination with chemotherapy and granted it priority review for the neoadjuvant treatment of patients with resectable non–small cell lung cancer.

“It's an exciting time with all the novel agent development in relapsed indolent lymphoma,” according to Brad S. Kahl, MD.

Even with the available agents and knowledge of when to select which option, there is an unmet medical need in the chronic lymphocytic leukemia landscape, according to Jennifer R. Brown, MD, PhD.

The phase 2/3 RINGSIDE clinical trial of AL102 has reached a key enrollment milestone.

Data supporting zanubrutinib for the treatment of chronic lymphocytic leukemia or small lymphocytic leukemia will undergo a regular FDA review in consideration for FDA approval.

Significant survival improvement has been shown with trastuzumab deruxtecan in patients with HER2-low breast cancer treated in the DESTINY-Breast04 clinical trial.

A new study is looking into the safety, tolerability, and preliminary efficacy of ZB131 in patients with advanced solid tumors.