The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes who harbor IDH1 mutations.
The FDA’s Oncologic Drugs Advisory Committee voted in support of approving pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
IMGN632, an investigational anti-CD123 antibody-drug conjugate, demonstrated preliminary activity in patients with relapsed/refractory acute myelogenous leukemia or blastic plasmacytoid dendritic cell neoplasm.
A biologics license application has been filed with the FDA for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
The FDA’s Oncologic Drugs Advisory Committee voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.
A new drug application has been submitted to the FDA seeking an accelerated approval for lurbinectedin for use as a second-line treatment for patients with small cell lung cancer.
The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer.
Zanubrutinib did not show a statistically significant improvement in complete response and very good partial response rates compared with ibrutinib in patients with Waldenström macroglobulinemia, missing the primary endpoint of the phase III ASPEN trial.
The investigational Bruton tyrosine kinase inhibitor ARQ 531 demonstrated safety and clinical activity across a range of B-cell malignancies.
A new drug application has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors who have previously received treatment with imatinib, sunitinib, and regorafenib.
Treatment with entrectinib led to an overall response rate of 77% and a median duration of response of 24.6 months in patients with ROS1 fusion–positive non–small cell lung cancer, according to updated findings of a pooled analysis published in Lancet Oncology.
Robert J. Motzer, MD, discusses the current frontline treatment landscape of metastatic renal cell carcinoma amongst an influx of approvals.
Jeff P. Sharman, MD, discusses updated data from the ELEVATE-TN trial and ongoing research that is poised to define the optimal role of acalabrutinib in chronic lymphocytic leukemia.
Casey M. Cosgrove, MD, discusses later-line treatments in ovarian cancer and ongoing research.
The triplet regimen of atezolizumab, cobimetinib, and vemurafenib was found to improve progression-free survival compared with cobimetinib/vemurafenib plus placebo in patients with previously untreated BRAF V600 mutation–positive advanced melanoma.
A biologics license application has been submitted to the FDA for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.
The FDA has approved 2 abbreviated new drug applications for everolimus (Afinitor) tablets for the treatment of patients with select malignancies.
Top researchers will present abstracts on latest clinical research advancing cancer treatment options.
Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was associated with a 73.4% overall response rate in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial.
Daniel Stover, MD, discusses unmet needs in patients with ESR1-mutant breast cancer, his hopes for lasofoxifene in that setting, and ongoing research efforts examining novel agents and approaches in the pipeline.
The investigational gene therapy nadofaragene firadenovec demonstrated a 3-month complete response rate of 53% in patients with high-grade, Bacillus Calmette-Guérin–unresponsive, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial.
The FDA’s Oncologic Drugs Advisory Committee will not be reviewing an sBLA for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes.
Eytan M. Stein, MD, discusses the introduction of novel agents, the relevancy of chemotherapy, and assessing minimal residual disease in acute myeloid leukemia.
Hope S. Rugo, MD, FASCO, discusses the research being done to develop more effective therapies for patients with advanced hormone receptor–positive, HER2-negative breast cancer who harbor an ESR1 mutation.
