News

Based on the outcome of the confirmatory phase 3 OCEAN study, the FDA has requested melphalan flufenamide be withdrawn for patients with relapsed or refractory multiple myeloma.

In an interview with Targeted Oncology, Thomas Kipps, MD, PhD, explained the new treatment options and challenges being faced in the chronic lymphocytic leukemia space.

Frontline treatment with dostarlimab and chemotherapy reduced the risk of disease progression and led to better objective response rates and progression-free survival vs pembrolizumab in patients with metastatic non-squamous non–small cell lung cancer.

Preliminary findings from the KRYSTAL-1 and KRYSTAL-7 trials show the potential for adagrasib in combination with pembrolizumab for patients with non-small cell lung cancer who’s cancer harbors a KRASG12C mutation.

In an interview with Targeted Oncology, Tapan M. Kadia, MD, discussed e-selection inhibition, and other novel targets for acute myeloid leukemia therapy.

Anthony Belott as the new chief development officer for American Oncology Network.

Poorer outcomes were shown in Black patients with hormone receptor-positive breast cancer, including in patients with similar 21-gene recurrence scores.

Patients with low-grade upper tract urothelial cancer elicited a clinical benefit at the end of the phase 3 OLYMPUS study when treated with UGN-101.

In an interview with Targeted Oncology, David J. Straus, MD, discussed the newest data of the ECHELON-1 trial which he presented at the National Comprehensive Cancer Network 2022 Annual Congress: Hematologic Malignancies.

In an interview with Targeted Oncology, Glenn J. Hanna, MD, discussed the phase 2 study evaluating treatment with nivolumab in patients with high-risk oral proliferative leukoplakia.

An interim overall survival analysis of the novel therapy sitravatinib combined with nivolumab has cleared the way for a continuation of the phase 3 SAPPHIRE study in patients with advanced non-squamous non–small cell lung cancer.

Jason Westin, MD, MS, FACP, discusses recent developments in novel agents to treat and target aggressive lymphomas.

Based on phase 1 data of the AUGMENT-101 trial, the FDA has granted a breakthrough therapy designation to SNDX-5613 for patients with relapsed or refractory KMT2A rearranged acute leukemia.

In an interview with Targeted Oncology, Chad Tang, MD, The University of Texas MD Anderson Cancer Center, discussed background and implication of findings from the EXTEND trial.

Adaptive Biotechnologies announced the launch of its clonoSEQ ctDNA-based MRD assay for patients with diffuse large B-cell lymphoma.

Alexey Danilov, MD, PhD, provides an overview on the recent updates and research in the chronic lymphocytic leukemia space.

In patients with PSMA-positive metastatic castration-resistant prostate cancer, the PSMA-directed therapy with 177Lu-PSMA-617, led to significant improvement in radiographic progression-free survival.

The clinical hold for the development of BEAM-201 has been lifted, allowing investigators to assess the agent in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/ T-cell lymphoblastic lymphoma.

The FDA will conduct a regular review of the application submitted for approval of I/ONTAK in patients with persistent or recurrent cutaneous T-cell lymphoma.

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.