News

The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.

Robert Rifkin, MD, FACP, a hematology oncologist at the Rocky Mountain Cancer Centers, discusses the need for novel treatment options in the relapsed or refractory multiple myeloma population.

TPX-0046, a next-generation RET inhibitor demonstrated preliminary clinical activity in patients with RET-driven cancers who were treated in the phase 1/2 SWORD-1 clinical trial.

Gerardo Umanzor, MD, explains the potential benefits of oral paclitaxel and encequidar compared with the intravenous formulation for the treatment of metastatic breast cancer during the coronavirus disease 2019 pandemic.

The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer.

In an interview with Targeted Oncology, Axel Grothey, MD, discussed how HER2 has become an actionable target for gastrointestinal cancers and potential HER2-targeted treatments in the field as well as other interesting studies from the role trastuzumab plays in the space.

In an interview with Targeted Oncology, Thomas Hutson, DO, PharmD, reviewed findings from the CLEAR study and how these data are set to re-shape the treatment landscape of advanced renal cell carcinoma.

A supplemental biologics license application for brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursors acute lymphoblastic leukemia.

A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes.

Surgical oncology expertise has been expanded to local communities in North Texas after physicians from Texas Colon & Rectal Specialists, a large colorectal cancer practice in North Texas, have joined Texas Oncology, increasing The US Oncology Network’s reach.

The phase 3 ARMADA 2000 trial, which aims to determine the efficacy and safety of devimistat in combination with high-dose cytarabine and mitoxantrone compared to controls for older patients with relapsed or refractory acute myeloid leukemia, has crossed the enrollment of 150 participants.

The standard dose of lenvatinib, 18 mg per day, demonstrated an improved health-related quality of life and a longer time to deterioration over a lower starting dose of lenvatinib, 14 mg per day, in patients with renal cell carcinoma, according to secondary results from a phase 2 trial.

A New Drug Application has been submitted to the FDA for the combination of plinabulin and granylocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

A rolling submission of a New Drug Application has been completed for pacritinib which is seeking FDA approval as a treatment for patients with myelofibrosis who have severe thrombocytopenia.

Here is a look back at the FDA happenings from the month of March 2020.

The FDA has granted Breakthrough Therapy Designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.

In an interview with Targeted Oncology, Curtis Lachowiez, MD, discussed the findings from the study of venetoclax added to the FLAG-ID regimen for the treatment of patients with secondary or R/R AML.

The FDA has granted approval to the combination of isatuximab added to carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

In patients with polycythemia vera, long-term use of the histone deacetylase inhibitor givinostat may be warranted after the agent demonstrated tolerable safety and good efficacy over a 4-year period in an ongoing, multicenter, open-label, single-arm study of patients with a chronic myeloproliferative neoplasm who are positive for a JAK2 V617F mutation.

Paul C. Boutros, PhD, MBA, discusses the different challenges facing prostate cancer genetic testing in the academic and community settings.

The FDA has granted fast track designation to Annamycin for the treatment of soft tissue sarcoma lung metastases, according to a press release from Moleculin Biotech, Inc.

The FDA has revised the approval of daunorubicin and cytarabine to add 2 new indications for the treatment of newly diagnosed therapy-related acute myeloid leukemia or for AML with myelodysplasia-related changes in pediatric patients aged 1 year and older.

In an interview with Targeted Oncology, John N. Allan, MD, a hematology oncologist at Weill Cornell Medicine, discussed how ibrutinib extends PFS in patients with CLL. He also discussed combination therapy in the future of CLL treatment.

The FDA has issued a complete response letter to Merck’s supplemental Biologics License Application which sought FDA approval of pembrolizumab as treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment.

Gilteritinib showed improvement in overall survival in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia compared with chemotherapy, meeting the primary end point of the phase 3 COMMODORE confirmatory trial.

In patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors that fail to respond to the standard therapy, the novel anti-PD-1 inhibitor, HLX10, has demonstrated positive efficacy and safety outcomes in a phase 2 clinical trial.

Oncologists deciding what to do about coronavirus disease 2019 vaccines are not alone.

The rolling submission of a Biologics License Application for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia has been completed for submission to the FDA.

Debu Tripathy, MD, discusses the role that margetuximab will have in the field of HER2-positive metastatic breast cancer now that it is approved by the FDA.

In an interview with Targeted Oncology, Erika P. Hamilton, MD, explained how hormone receptor status in patients with HER2-positive breast cancer was affected by treatment with the HER2CLIMB regimen of tucatinib plus trastuzumab and capecitabine.