Jason M. Broderick

The FDA’s Oncologic Drugs Advisory Committee voted 8-3 against approving a new drug application for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.

The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals, the manufacturer of the PD-1 inhibitor.

The FDA has approved erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy.

Findings from the phase III NEJ026 study, presented at the 2018 ASCO Annual Meeting and now published in Lancet Oncology, showed that adding bevacizumab to erlotinib significantly improved progression-free survival versus erlotinib alone in patients with EGFR-positive, advanced nonsquamous non–small cell lung cancer.

The R2 regimen of lenalidomide plus rituximab significantly reduced the risk of disease progression or death compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma, according to results from the pivotal phase III AUGMENT trial.

The FDA has added 3 months to the review period for a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia, allowing the agency to review additional data provided by Daiichi Sankyo.

The European Commission has approved dacomitinib for the frontline treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR-activating mutations.

Enfortumab vedotin showed strong clinical activity in patients with locally advanced or metastatic urothelial carcinoma who previously received both platinum-containing chemotherapy and immune checkpoint therapy, according to topline results from the pivotal phase II EV-201 trial.

The FDA has placed a partial clinical hold on all clinical trials examining venetoclax in multiple myeloma, halting enrollment of new patients on the studies.

The FDA has added 3 months to the review period for a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma, making the new action date July 6, 2019.

A supplemental biologics license application has been submitted to the FDA for the approval of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of lorlatinib for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK TKI, or crizotinib and at least one other ALK TKI.

Pre-existing cardiovascular disease was associated with an increased mortality risk during the first 6 months of abiraterone acetate treatment in patients with advanced prostate cancer.

The FDA’s Oncologic Drugs Advisory Committee voted against accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial.

The FDA has granted a priority review designation to a supplemental new drug application for the R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) for use in patients with previously treated follicular lymphoma and marginal zone lymphoma.

The FDA has approved TAS-102 (trifluridine/tipiracil; Lonsurf) for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

The FDA has granted a priority review to a supplemental new drug application for ivosidenib for the frontline treatment of patients IDH1-mutant acute myeloid leukemia who are ineligible for standard chemotherapy.

The FDA has granted a priority review designation to polatuzumab vedotin for use in combination with bendamustine and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

Nivolumab combined with low-dose ipilimumab continued to demonstrate strong responses and a survival benefit at 30 months’ follow-up as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.

The novel targeted radiation therapy lutetium-177 PSMA-617 showed strong clinical activity and the potential to improve survival in heavily pretreated men with PSMA-positive metastatic castration-resistant prostate cancer.

The European Commission has approved brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.

The European Commission has approved dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The FDA has added 3 months to the review period for a supplemental new drug application for ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.

Genentech has completed its FDA submission of a supplemental Biologics License Application for ado-trastuzumab emtansine as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of dacomitinib for the frontline treatment of adult patients with metastatic non–small cell lung cancer with EGFR-activating mutations.

A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab (Darzalex) for use in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of certain patients with multiple myeloma.

The European Commission has approved blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.

The European Commission has approved nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.

The FDA has approved cabozantinib as a treatment for patients with hepatocellular carcinoma who previously received sorafenib.

The FDA has extended the review period for a supplemental biologics license application for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with a PD-L1 expression level of ≥1% and no EGFR or ALK genomic tumor aberrations.