Jason M. Broderick

Among patients with HR+/HER2- or triple-negative metastatic breast cancer, nab-paclitaxel (Abraxane) improved time to treatment discontinuation, time to next treatment, and had a favorable safety profile compared with paclitaxel.

The rapid advance of oncology drug development requires evolving beyond using overall survival in randomized trials as the only acceptable endpoint.

The FDA has approved ibrutinib (Imbruvica) for the frontline treatment of chronic lymphocytic leukemia based on data from the RESONATE-2 trial.

A supplemental biologics license application has been submitted to the FDA to expand the approval of blinatumomab (Blincyto) to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Afatinib has received a positive opinion from the CHMP, recommending European approval for use in patients with advanced squamous cell non–small cell lung cancer following progression on platinum-based chemotherapy.

The FDA approved obinutuzumab (Gazyva) plus bendamustine followed by obinutuzumab alone for the treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy.

The FDA has approved palbociclib (Ibrance) for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer.

The anti-CD19 agent blinatumomab (Blincyto) induced a response rate of 69% in patients with non-Hodgkin Lymphoma.

A combination checkpoint blockade with the PD-L1 inhibitor durvalumab and the anti–CTLA-4 agent tremelimumab induced a response rate of 23% in patients with advanced non–small cell lung cancer.

An affinity enhanced T-cell therapy has received an FDA breakthrough therapy designation for the treatment of patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen.

Sacituzumab govitecan (IMMU-132) has received an FDA breakthrough therapy designation for the treatment of patients with triple-negative breast cancer following at least 2 treatments for metastatic disease.

The phase III TOWER study has been halted after an independent panel determined that blinatumomab (Blincyto) improved overall survival versus standard chemotherapy in patients with Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The FDA approved single-dose fosaprepitant dimeglumine (Emend for injection) in combination with other antiemetic agents for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC), according to Merck, the developer of the drug.

The FDA issued a complete response letter to Telesta Therapeutics informing the company that its biologics license application for MCNA in bladder cancer would not be approved and that an additional phase III clinical trial was needed to adequately evaluate the immunotherapy.

Venetoclax has received an FDA breakthrough therapy designation for use in combination with hypomethylating agents in treatment-naïve patients with acute myeloid leukemia who are not eligible for standard high-dose induction treatment.

The FDA has expanded the frontline melanoma indications for nivolumab as a single agent and in combination with ipilimumab to include patients with BRAF mutations.

The PD-1 inhibitor nivolumab (Opdivo) had an overall response rate of 14% with an acceptable safety profile in patients with gastric or gastroesophageal junction cancer.

The FDA has approved carfilzomib (Kyprolis) in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy

Venetoclax has received an FDA breakthrough therapy designation for use in combination with rituximab to treat patients with relapsed/refractory chronic lymphocytic leukemia.

Everolimus reduced the risk of disease progression by at least 40% in patients with either gastrointestinal neuroendocrine tumors or NETs of unknown primary origin.

The FDA has approved ofatumumab (Arzerra) for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia who are in complete or partial response following at least two lines of therapy.

The FDA has assigned a priority review to venetoclax for use in adults with chronic lymphocytic leukemia, including patients with a 17p deletion, following at least 1 prior therapy.

Nivolumab’s second-line survival benefit in renal cell carcinoma was consistent across subgroups categorized by patient risk status, prior treatment, and degree of metastases, according to an update of the phase III CheckMate-025 trial.

Second-line treatment with atezolizumab (MPDL3280A) led to durable responses in patients with locally advanced or metastatic urothelial carcinoma.

Adding celecoxib and zoledronic acid to standard treatment extended survival in men with metastatic prostate cancer commencing first-line hormone therapy, according to updated data from the STAMPEDE trial.

Cabozantinib significantly improved progression-free survival versus everolimus in patients with renal cell carcinoma regardless of the degree of metastases, type or number of prior treatments, or patient risk status.

The FDA has expanded the approval for single-agent pembrolizumab to include the frontline treatment of patients with advanced melanoma regardless of BRAF status.

The PD-1 inhibitor pembrolizumab had an overall response rate of 12% in PD-L1–positive patients with ER-positive/HER2-negative advanced breast cancer.

T-DM1 (ado-trastuzumab emtansine; Kadcyla) reduced the risk of death by 32% and improved median overall surviva by almost 7 months compared with physician's choice of therapy in heavily pretreated patients with HER2-positive advanced breast cancer.

Estrogen receptor mutations are prevalent and associated with poorer survival in patients with pretreated HR+/HER2- metastatic breast cancer.