Jason M. Broderick

The FDA has granted a priority review to ceritinib as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer.

The FDA has approved lenalidomide (Revlimid) as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant.

The PARP inhibitor olaparib improved progression-free survival versus standard chemotherapy in patients with BRCA-positive, HER2-negative breast cancer, according to findings from the phase III OLYMPIAD trial.

A supplemental biologics license application has been submitted to the FDA for the full regulatory approval of blinatumomab as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.

Up to 94% of patients with metastatic castration-resistant prostate cancer have circulating tumor DNA with at least 1 genetic alteration, suggesting ctDNA could be a noninvasive alternative to traditional tumor biopsies and help personalize treatment in this setting.

The FDA has granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer who progress following platinum-containing chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of lenalidomide as a maintenance therapy following autologous stem cell transplant for patients with newly diagnosed multiple myeloma.

Frontline treatment with lenvatinib was shown to be noninferior to standard therapy with sorafenib in patients with unresectable hepatocellular carcinoma.

The promising antitumor activity of nivolumab in patients with microsatellite instability-high metastatic colorectal cancer was sustained in an update of the phase II CheckMate-142 trial.

Switching neoadjuvant chemotherapy regimens based on PET imaging after induction chemotherapy improved pathologic complete response rates in patients with esophageal and gastroesophageal junction cancers.

The FDA has granted a priority review to a supplemental new drug application for the use of the PD-L1 inhibitor atezolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma as a frontline therapy or following progression occurring ≥12 months after neoadjuvant or adjuvant chemotherapy.

The FDA has lifted its clinical hold on trials exploring pacritinib, according to CTI BioPharma, the developer of the JAK2/FLT3 inhibitor.

The FDA has granted a priority review to a supplemental new drug application for the use of regorafenib as a second-line treatment for patients with unresectable hepatocellular carcinoma.

The FDA has placed clinical holds on several phase I trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia, according to Seattle Genetics, the manufacturer of the antibody-drug conjugate.

The FDA has issued a complete response letter to Advanced Accelerator Applications informing the company that its new drug application for Lutathera as a treatment for patients with gastroenteropancreatic neuroendocrine tumors would need to be resubmitted.

The FDA has granted a priority review to a supplemental new drug application supporting the conversation of the accelerated approval of palbociclib (Ibrance) to a full approval for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.

The phase II HERMIONE trial was halted after the antibody-drug conjugate MM-302 combined with trastuzumab failed to improve progression-free survival versus chemotherapy plus trastuzumab in patients with HER2-positive metastatic breast cancer who had previously received trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

JCAR017 has received an FDA breakthrough therapy designation for the treatment of patients with relapsed/refractory, aggressive large B-cell non-Hodgkin lymphoma.

The FDA has granted a priority review to a new drug application for the PARP 1/2 inhibitor niraparib for use as a maintenance therapy in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy.

The benefits of 2 FDA-approved daratumumab–based triplet regimens were sustained in long-term data from 2 pivotal phase III studies presented at the 2016 ASH Annual Meeting.

The FDA has approved rucaparib (Rubraca) as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy, according to Clovis, the manufacturer of the PARP inhibitor

The Committee for Medicinal Products for Human Use has recommended approval of alectinib as a treatment for patients with metastatic ALK-positive non—small cell lung cancer following progression on crizotinib.

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of frontline pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer whose tumors do not harbor EGFR or ALK mutations.

Adding enzalutamide to abiraterone acetate failed to improve progression-free survival versus abiraterone alone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer who progressed on enzalutamide.

The European Commission has approved ofatumumab in combination with fludarabine and cyclophosphamide as a treatment for adult patients with relapsed chronic lymphocytic leukemia.

The FDA has granted a priority review to a biologics license application for the PD-L1 inhibitor durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed on standard platinum‑based chemotherapy.

A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial.

Adding the PARP inhibitor veliparib to carboplatin/paclitaxel chemotherapy induced a response rate of 77.8% in patients with advanced BRCA-positive breast cancer.

Subcutaneous delivery of daratumumab was well tolerated with comparable efficacy to the FDA-approved intravenous dose in patients with relapsed/refractory multiple myeloma.

Selinexor, in combination with dexamethasone, induced a response rate of 20.5% (n = 16) among 78 heavily pretreated patients with relapsed/refractory multiple myeloma, according to results from the phase IIb STORM trial presented at the 2016 ASH Annual Meeting.