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Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.

Treatment with SGX301 led to statistically significant responses in patients with cutaneous T-cell lymphoma, according to preliminary top-line results from the pivotal phase III FLASH trial released by Soligenix.

Tatyana Feldman, MD, director of T cell program at the John Theurer Cancer Center, Hackensack Meridian Health, discusses how research is now building upon the positive results from the phase III ECHELON-1 study, which was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.<br /> &nbsp;

The FDA has placed a partial clinical hold on the phase I trial of ACTR707 in combination with rituximab in patients with relapsed/refractory B-cell lymphoma from Unum Therapeutics, following the submission of a safety report from the company. The FDA notified Unum of the hold verbally on March 4. Unum Therapeutics acknowledged the partial clinical hold in filings with the Securities and Exchange commission.

After demonstrating promising results that were comparable to targeted therapies in the first 2 cohorts of a phase I clinical trial, the combination of cladribine, cytarabine, granulocyte-colony stimulating factor, and mitoxantrone plus the antibody radiation conjugate lintuzumab-Ac225 in patients with relapsed/refractory acute myeloid leukemia is now being explored in a third cohort.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.

The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.

Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma , meeting a dual primary end point of the phase III KEYNOTE-204 trial, according to the interim analysis results announced in press release from Merck.