Silas Inman

The FDA has granted an accelerated approval olaratumab in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma who are not good candidates for radiotherapy or surgery.

The combination of custirsen with docetaxel failed to significantly extend overall survival compared with docetaxel alone as a second-line treatment for patients with non–small cell lung cancer.

Adjuvant sunitinib prolonged disease-free survival by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell renal cell carcinoma.

Single-agent pembrolizumab improved overall and progression-free survival compared with doublet chemotherapy for untreated patients with advanced non–small cell lung cancer who expressed PD-L1 on ≥50% of cells.

Maintenance therapy with niraparib reduced the risk of progression or death by 73% compared with placebo for patients with germline BRCA-positive platinum-sensitive, recurrent ovarian cancer.

The FDA has granted a priority review designation to daratumumab (Darzalex) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.

The preferred primary therapy for patients with multiple myeloma is induction therapy with a triplet regimen followed by autologous stem cell transplantation, consolidation, and maintenance.

As generic imatinib enters the market, new questions focus on a renewed role for the agent in conjunction with second-generation TKIs.

Treatment with KTE-C19 demonstrated an objective response rate of 79% and a complete remission rate of 52% for patients with aggressive, chemorefractory non-Hodgkin's lymphoma.

Carfilzomib did not improve progression-free survival compared with bortezomib when used in combination with melphalan and prednisone as a treatment for transplant ineligible patients with newly diagnosed multiple myeloma.

The combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved progression-free survival compared with single-agent vemurafenib for patients with BRAF-mutant melanoma.

The FDA has accepted a new drug application for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab.

The CHMP has recommended a conditional approval for ixazomib in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.

The FDA has granted a fast track designation to niraparib, allowing the initiation of a rolling submission of data for potential approval for the PARP inhibitor as a treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

The FDA has assigned a standard review designation to a new drug application for binimetinib as a treatment for patients with NRAS-mutant advanced melanoma.

The European Commission has approved crizotinib (Xalkori) as a treatment for patients with advanced ROS1-positive non–small cell lung cancer.

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

A new drug application has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non–small cell lung cancer following resistance or intolerance to crizotinib (Xalkori).

Treatment with pacritinib significantly reduced spleen volume but failed to improve total symptom score compared with best available therapy for thrombocytopenic patients with high-risk myelofibrosis.

Pfizer has announced plans to acquire the biopharmaceutical company Medivation, which is the developer of the androgen receptor inhibitor enzalutamide (Xtandi).

Treatment with single-agent BCL-2 inhibitor venetoclax demonstrated an overall response rate of 19% with a tolerable safety profile in patients who were unfit for intensive chemotherapy for those with relapsed/refractory acute myeloid leukemia.

The combination of selumetinib and docetaxel failed to improve survival compared with docetaxel alone as a second-line treatment for patients with KRAS-mutant locally advanced or metastatic non–small cell lung cancer.

The FDA has granted an accelerated approval to pembrolizumab as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma following progression on a platinum-based chemotherapy.

Monotherapy with nivolumab failed to improve progression-free survival compared with physician's choice of combination chemotherapy for patients with PD-L1–positive non–small cell lung cancer.

The FDA has granted a breakthrough therapy designation to the CDK4/6 inhibitor ribociclib in combination with letrozole for its potential as a frontline therapy for patients with HR-positive, HER2-negative advanced breast cancer.

Ibrutinib (Imbruvica) and idelalisib (Zydelig) have become standard of care treatments for patients with relapsed or high-risk chronic lymphocytic leukemia, with ongoing studies in progress to move ibrutinib into the frontline setting.

Treatment with vemurafenib (Zelboraf) demonstrated an objective response rate of up to 38.5% for patients with radioactive iodine-refractory BRAF V600E-mutant papillary thyroid cancer who were multikinase inhibitor-naive.

A phase I/II study will explore the delta-like protein 3-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer.

The Committee for Medicinal Products for Human Use has recommended the approval of pegylated liposomal irinotecan (Onivyde) 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 adopted a positive option for crizotinib (Xalkori) as a treatment for adults with ROS1-positive advanced non–small cell lung cancer, suggesting an approval may be imminent.