Gina Columbus

Gilteritinib was found to significantly improve overall survival in patients with relapsed/refractory FLT3 mutation–positive acute myeloid leukemia, according to updated findings of the phase III ADMIRAL trial.

The PI3K-delta inhibitor umbralisib was found to demonstrate an overall response rate of 52% and show an encouraging tolerability profile in patients with relapsed/refractory marginal zone lymphoma, according to findings from a cohort of the phase IIb UNITY-NHL trial.

The combination of osimertinib and the MET inhibitor savolitinib demonstrated encouraging clinical activity and an acceptable risk-benefit profile in patients with EGFR-mutant, MET-amplified non–small cell lung cancer who previously received EGFR TKIs.

The administration of HER2-directed CAR T-cell therapy and lymphodepletion chemotherapy demonstrated antitumor activity and was found to be safe in pediatric and adult patients with advanced HER2-positive sarcoma.

An accelerated filing of a biologics license application is planned for [fam-] trastuzumab deruxtecan (DS-8201) as a treatment for patients with HER2-positive metastatic breast cancer previously treated with ado-trastuzumab emtansine.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted positive opinions to 2 triplet regimens with immunomodulatory agents for patients with multiple myeloma.

A Type II variation application has been submitted to the European Medicines Agency for the 4-drug regimen of daratumumab, bortezomib, thalidomide, and dexamethasone as a treatment for patients with newly diagnosed multiple myeloma who are eligible to undergo autologous stem cell transplant.

The FDA has granted a breakthrough therapy designation to the combination of ivosidenib and azacitidine for the treatment of newly diagnosed patients with IDH1-mutant acute myeloid leukemia ≥75 years old or are ineligible for intensive induction chemotherapy.

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

Lurbinectedin as monotherapy was found to elicit responses in patients with relapsed small cell lung cancer, meeting the primary endpoint of a phase II trial by both investigator review and an independent review committee.

A Type II variation application has been submitted to the European Medicines Agency for the combination of daratumumab with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The investigational antibody-drug conjugate GSK2857916 continued to improve progression-free survival in patients with relapsed/refractory multiple myeloma, according to results of a final analysis of the DREAMM-1 study.

The ongoing phase III JAVELIN Ovarian PARP 100 study, which was evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance avelumab in combination with talazoparib in patients with locally advanced or metastatic ovarian cancer, has been discontinued.

FLT3 inhibition continues to be explored as a therapeutic option for patients with FLT3-mutant acute myeloid leukemia, with quizartinib at the forefront following intriguing results of the phase III QuANTUM-R trial.

The FDA has granted an approval to the combination of atezolizumab with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.

Atezolizumab (Tecentriq) demonstrated consistent safety and efficacy with prior studies of the PD-L1 inhibitor in patients with locally advanced or metastatic urothelial carcinoma, including clinically relevant subgroups reflective of real-world clinical practice.

Spectrum Pharmaceuticals has voluntarily withdrawn their biologics license application for eflapegrastim, due to the company needing more time to complete the FDA’s request for additional manufacturing-related information.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted an Early Access to Medicines Scheme positive scientific opinion to atezolizumab in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The European Commission has approved pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the frontline treatment of patients with metastatic squamous non–small cell lung cancer.

AR-V7 protein in circulating tumor cells is a predictive marker of shorter progression-free and overall survival with antiandrogen therapy in patients with metastatic castration-resistant prostate cancer.

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 adjuvant combination of nab-paclitaxel and gemcitabine was not found to improve disease-free survival compared with gemcitabine alone, as confirmed by independent radiological review, in patients with pancreatic cancer.

The combination of ramucirumab and erlotinib significantly improved progression-free survival compared with placebo and erlotinib as a frontline treatment for patients with metastatic EGFR-mutant non–small cell lung cancer, meeting the primary endpoint of the RELAY trial (NCT02411448).

The FDA has granted an approval to PF-05280014 (Trazimera; trastuzumab-qyyp), a trastuzumab biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The European Commission has approved and granted marketing authorization to the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer.

A supplemental new drug application has been filed for the combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions.

An application has been submitted to Japan's Ministry of Health, Labor and Welfare for darolutamide for the treatment of patients with castration-resistant prostate cancer.

The FDA has granted a priority review designation to a new drug application for fedratinib as a treatment for patients with myelofibrosis.

Suman A. Kambhampati, MD, discusses emerging data in myeloproliferative neoplasms and what is coming on the horizon.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a new extended dosing schedule for pembrolizumab for all of the PD-1 inhibitor’s monotherapy indications in the European Union.