Jason M. Broderick

The FDA has granted pembrolizumab an accelerated approval for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy.

The FDA approved a supplemental new drug application adding overall survival data from the phase III ASPIRE trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma.

The FDA has granted a regular approval to venetoclax for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, following at least 1 prior therapy. The BCL-2 inhibitor is now also approved for use in combination with rituximab in the same patient population.

The FDA has granted a priority review to a new drug application for talazoparib for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer.

Combining olaparib (Lynparza) with abiraterone acetate (Zytiga) reduced the risk of disease progression or death by 35% compared with abiraterone alone in pretreated patients with metastatic castration-resistant prostate cancer.

Combining the CD122-biased cytokine NKTR-214 with the PD-1 inhibitor nivolumab (Opdivo) showed promising antitumor activity, particularly in PD-L1–negative patients.

The PD-1 inhibitor cemiplimab induced an overall response rate of 47.5% in patients with metastatic cutaneous squamous cell carcinoma.

Combining pegilodecakin with nivolumab or pembrolizumab induced an overall response rate of 41% in patients with advanced non–small cell lung cancer.

Adding pembrolizumab to frontline carboplatin/paclitaxel or nab-paclitaxel reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous non–small cell lung cancer.

The addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel (Abraxane) delayed the risk of progression or death by 29% compared with chemotherapy alone for patients with advanced squamous NSCLC.

Adding ibrutinib to rituximab lowered the risk of disease progression or death by 80% versus rituximab alone in patients with Waldenström macroglobulinemia.

Adding pomalidomide (Pomalyst) to bortezomib (Velcade) and low-dose dexamethasone reduced the risk of disease progression or death by 39% in patients with relapsed/refractory multiple myeloma with prior exposure to lenalidomide.

The FDA has granted a priority review to a supplemental new drug application for eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia.

The FDA has granted crizotinib a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations, and for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.

Adding atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) and carboplatin in the frontline setting significantly improved overall survival in patients with advanced non–small cell lung cancer.

The FDA has granted a priority review to a new drug application for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia.

The FDA has granted a priority review to a new drug application for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion.

Durvalumab significantly improved overall survival versus placebo when used as a sequential treatment in patients with locally-advanced, unresectable non–small cell lung cancer who had not progressed following standard chemoradiotherapy, according to updated findings from the phase III PACIFIC trial.

Adding ofatumumab (Arzerra) to bendamustine (Treanda) failed to improve progression-free survival in patients with indolent B-cell non-Hodgkin lymphoma who did not respond to rituximab (Rituxan) monotherapy.

Frontline treatment with the combination of ibrutinib (Imbruvica) and obinutuzumab (Gazyva) improved progression-free survival compared with chlorambucil plus obinutuzumab in patients with CLL or SLL.

Apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer, according to a posthoc analysis from the phase III SPARTAN trial.

The European Commission has approved cabozantinib (Cabometyx) for previously untreated patients with intermediate- or poor-risk advanced renal cell carcinoma.

Adding nelarabine to escalating-dose methotrexate induced a 4-year disease-free survival rate of 91% in a cohort of pediatric and young adult patients with newly diagnosed T-cell cancers.

Combination therapy with the PD-L1 inhibitor atezolizumab and the MEK inhibitor cobimetinib failed to improve overall survival versus regorafenib in previously treated patients with locally advanced or metastatic colorectal cancer, according to topline findings from the phase III IMblaze370 study.

Findings from the phase III TAGS trial showed that TAS-102 (trifluridine/tipiracil; Lonsurf) extended overall survival in previously treated patients with metastatic gastric cancer.

The European Commission has approved olaparib tablets (Lynparza) as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer.

Quizartinib improved overall survival compared with chemotherapy in patients with FLT3-ITD–positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation, according to findings from the phase III QuANTUM-R study.

The FDA has granted a priority review to a supplemental biologics license application for atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.

The National Institute for Health and Care Excellence has authorized the use of midostaurin in combination with standard chemotherapy for the treatment of patients with newly diagnosed FLT3-positive acute myeloid leukemia.

A supplemental biologics license application has been submitted to the FDA for the use of pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer.