News

Edward B. Garon, MD, MS, provides an overview of the phase 3 CANOPY-A study.

Here is a look back at the FDA happenings from the month of November 2022.

Eprenetapopt combined with azacitidine as maintenance therapy after hematopoietic stem-cell transplant induced encouraging relapse-free and overall survival in patients with TP53-mutant acute myeloid leukemia and myelodysplastic syndrome.

The phase 2 RUBY clinical trial has met its primary end point with dostarlimab-gxly given after chemotherapy achieving progression-free survival improvement in adult patients with primary advanced or recurrent endometrial cancer.

The FDA has granted a fast track designation to the combination of pelareorep and atezolizumab with gemcitabine and nab-paclitaxel for advanced or metastatic pancreatic ductal adenocarcinoma after promising results were presented from the GOBLET study at the SITC Annual Meeting.

Positive and durable complete responses observed with olutasidenib in adult patient with relapsed or refractory acute myeloid leukemia and a susceptible IDH1 mutation have led the FDA to grant approval to the drug for this group of patients

Patients with multiple myeloma administered daratumumab in combination with bortezomib and dexamethasone demonstrated improvements in overall survival compared with those given bortezomib and dexamethasone alone.

Lajos Pusztai, MD, DPhil, discusses recent data from the phase 3 KEYNOTE-522 trial of patients with triple-negative breast cancer.

The phase 1 INSIGHT-005 trial will further evaluate the combination of eftilagimod alpha and avelumab in patients with metastatic urothelial cancer.

In an interview with Targeted Oncology, Christopher R. D’Angelo, MD discussed recent approvals in the multiple myeloma space and how to treat patients using immunotherapy.

The allogeneic CAR T-cell therapy CB-010 received regenerative medicine advanced therapy and Fast Track designations for the treatment of patients with B-cell non-Hodgkin lymphoma.

Gene G. Finley, MD, discusses some of the challenges seen when treating patients with small cell lung cancer.

Findings from the phase 1 CALM study evaluating the allogeneic genome-edited anti-CD19 chimeric antigen receptor T-cell product UCART19 show it can be safely used for patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Tycel Phillips, MD, discusses recent changes in the mantle cell lymphoma treatment landscape.

Following positive new data from a phase 1/2 study examining batiraxcept in patients with clear cell renal cell carcinoma, the agent has been granted fast track designation by the FDA.

Takeda Pharmaceuticals announced that the phase 3 PhALLCON trial of ponatinib for Philadelphia-positive acute lymphoblastic leukemia succeeded in improving the rate of minimal residual disease–negative complete remission.

Clinically meaningful differentiation across efficacy measures were seen in patients administered domvanalimb in combination with zimberleimab or etrumadenant vs zimberelimab monotherapy.

Fast track designation has been granted to REM-001 therapy for patients with cutaneous metastatic breast cancer based on positive data from 4 phase 2/3 studies.

In an interview with Targeted Oncology, Chelsea C. Pinnix discussed the results of a phase 2 study and how these promising results will shift the treatment paradigm of patients with orbital indolent B-cell lymphoma.

Results from the ARIES trial continue to show the benefit of avelumab monotherapy as a first-line drug for patients with metastatic urothelial cancer with PD-L1 expression.

Colorectal cancer screenings are effective at saving lives, according to Florida Cancer Specialists & Research Institute.

On the heels of a negative ODAC vote, poziotinib has was not approved by the FDA on it PDUFA date, and the developer of poziotinib will stop development immediately.

Favorable long-term survival rates and manageable rates of graft-vs-host disease were elicited with omidubicel in patients with hematologic malignancies who underwent allogeneic stem cell transplant.

Marcia S. Brose, MD, PhD, FASCO, discusses NTRK gene fusions and identifying patients with thyroid cancer.

Updated analysis from the phase 1/2 ARROW study evaluating pralsetinib in patients with RET fusion-positive non–small cell lung cancer showed the agent to be well tolerated and to elicit clinical activity at a dose of 400 mg daily.

Tepotinib plus gefitinib led to improvements in progression-free survival and overall survival in patients with EGFR-mutant non–small cell lung cancer.

A 5-year survival update of CheckMate 227 support the use of nivolumab plus ipilimumab in patients with advanced non–small cell lung cancer.

In an interview with Targeted Oncology, Jia Ruan, MD, PhD, discussed the updates in the mantle cell lymphoma space, including understanding molecular pathogenesis and risk stratification for this patient population.

Investigators in the IT-01 trial of INT230-6 as monotherapy or combined with ipilimumab showed safety and potential efficacy in patients with sarcoma.

In an interview with Targeted Oncology, Srdan Verstovsek, MD, discussed the current MPN treatment landscape and where the field is shifting.