Jason M. Broderick

The FDA has granted a full approval and label update to ponatinib for patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor therapy is indicated, as well as for patients with T315I-positive CML or T315I-positive Ph+ ALL.

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced microsatellite instability-high cancer.

For a second time, a clinical hold has been placed on the phase II ROCKET study exploring the CD19-targeted CAR T-cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

The European Commission has approved nivolumab for the treatment of patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.

The FDA has approved daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy, based on findings from the phase III POLLUX and CASTOR studies.

The FDA has issued a complete response letter to Spectrum Pharmaceuticals informing the company that its new drug application for apaziquone in bladder cancer would not be approved.

Outcomes were mixed for momelotinib in topline results from 2 phase III myelofibrosis trials announced by Gilead Sciences, the company developing the investigational JAK1/2 inhibitor.

Cabozantinib reduced the risk of progression or death by 34% versus sunitinib as a first-line treatment for patients with metastatic renal cell carcinoma, according to results from the phase II CABOSUN trial.

PARP inhibition is quickly becoming a major element of the overall ovarian cancer treatment landscape, as several of these agents are continuing to advance through clinical development.

The FDA granted a priority review to a new drug application for midostaurin (PKC412) for adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia or advanced systemic mastocytosis.

The Committee for Medicinal Products for Human Use has recommended approval of ofatumumab in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia.

Brentuximab vedotin (Adcetris) has received an FDA breakthrough therapy designation for the treatment of patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large cell lymphoma following at least 1 prior systemic therapy.

The FDA has approved nivolumab for patients with metastatic or recurrent squamous cell carcinoma of the head and neck following progression on platinum-based therapy.

Impactful clinical trial data that have led to approvals of novel agents and regimens over the last few years has led to a significant transformation in the multiple myeloma landscape.

The European Commission approved palbociclib (Ibrance) for use in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer, either in combination with an aromatase inhibitor in the frontline setting or combined with fulvestrant after progression on endocrine therapy.

A supplemental new drug application has been submitted to the FDA for the use of regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma.

A new drug application to the FDA has been completed for niraparib as a maintenance treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

The FDA granted a priority review to ribociclib for use in combination with letrozole as a frontline therapy for patients with hormone-receptor–positive, HER2-negative advanced breast cancer.

The FDA has has granted a priority review to a new drug application for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer who are resistant to prior crizotinib.

Updated results from the CheckMate-205 trial showed that nivolumab had an objective response rate of 73% in a cohort of patients with classical Hodgkin lymphoma who received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation.

The FDA has approved pembrolizumab (Keytruda) for the frontline treatment of patients with metastatic non­–small cell lung cancer whose tumors have ≥50% PD-L1 expression based on an FDA-approved test and who do not harbor EGFR or ALK aberrations.

The FDA has updated the label for enzalutamide in metastatic castration-resistant prostate cancer to include new data from the phase II TERRAIN study.

Pembrolizumab improved survival compared with chemotherapy in previously treated patients with advanced urothelial cancer in the phase III KEYNOTE-045 trial.

The FDA has approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring EGFR or ALK abnormalities.

The European Commission has approved pegylated liposomal irinotecan in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.

The Committee for Medicinal Products for Human Use has recommended approval of venetoclax for the treatment of patients with chronic lymphocytic leukemia who have a 17p deletion (del[17p]) or TP53 mutation and are not good candidates for or have failed on a B-cell receptor pathway inhibitor. The potential indication would also be for patients who do not harbor the deletion or mutation but have progressed on both a BCR inhibitor and chemoimmunotherapy.

The Committee for Medicinal Products for Human Use has recommended approval of nivolumab for the treatment of patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.

Cabozantinib (Cabometyx) reduced the risk of progression or death by 31% compared with sunitinib (Sutent) in the frontline setting for patients with metastatic renal cell carcinoma.

Atezolizumab (Tecentriq) reduced the risk of death by 27% compared with docetaxel in patients with advanced non–small cell lung cancer following the failure of platinum-based chemotherapy.

Treatment with ipilimumab reduced the risk of death by 28% versus placebo in patients with high-risk stage III melanoma.