Jason M. Broderick

Regorafenib (Stivarga) improved overall survival versus best supportive care in patients with unresectable hepatocellular carcinoma who progressed after receiving sorafenib (Nexavar).

The FDA has granted the PDGFRα antagonist olaratumab a priority review for use in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma who are not good candidates for radiotherapy or surgery.

The FDA has granted a priority review to an application 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.

Obinutuzumab (Gazyva) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use for use in combination with bendamustine as a treatment for patients with follicular lymphoma who previously received chemotherapy.

Everolimus (Afinitor) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use as a treatment for patients with progressive, unresectable or metastatic, well-differentiated nonfunctional gastrointestinal or lung neuroendocrine tumors.

The FDA has approved cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.

Given the numerous available treatment options, the most important issue in frontline colorectal cancer care is clarifying the goals of therapy.

First-line treatment with single-agent osimertinib (Tagrisso) induced a response rate of 77% in patients with EGFR-mutated non–small cell lung cancer.

The FDA has granted nivolumab (Opdivo) a priority review for use in previously treated patients with classical Hodgkin lymphoma.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib as a treatment for patients with metastatic EGFR T790M–mutated non–small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.

The FDA approved the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy.

The FDA has granted a priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non–small cell lung cancer who express PD-L1 and have progressed after a platinum-containing regimen.

The European Commission has approved nivolumab (Opdivo) for use in previously treated patients with advanced renal cell carcinoma.

The European Commission has approved nivolumab (Opdivo) for the treatment of patients with nonsquamous non–small cell lung cancer, regardless of PD-L1 levels.

Eribulin mesylate (Halaven) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy.

Single-agent daratumumab (Darzalex) for the treatment of patients with relapsed/refractory multiple myeloma previously treated with a proteasome inhibitor and an immunomodulatory agent has received a positive recommendation from the Committee for Medicinal Products for Human Use.

At the 2016 NCCN Annual Conference, William J. Gradishar, MD, discussed updates to the NCCN Breast Cancer Guideline and the latest research developments in the field.

Adding plitidepsin (Aplidin) to dexamethasone reduced the risk of disease progression by 35% versus dexamethasone alone in patients with relapsed/refractory multiple myeloma enrolled in the phase III ADMYRE trial.

The European Medicines Agency validated an application for use of nivolumab (Opdivo) for previously treated patients with classical Hodgkin lymphoma), which officially begins the centralized review process for final approval of the drug in the European Union.

Adding daratumumab (Darzalex) to standard bortezomib (Velcade) and dexamethasone improved progression-free survival in patients with relapsed/refractory multiple myeloma enrolled in the phase III CASTOR (MMY3004) trial.

Patients with advanced ovarian cancer harboring mutations in homologous recombination (HR) genes, including BRCA1/2, had improved survival outcomes versus patients without HR mutations.

The FDA has granted a priority review to atezolizumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

The FDA has approved Captisol-enabled melphalan (Evomela) as a high-dose conditioning treatment for use in patients with multiple myeloma prior to autologous stem cell transplantation, as well as for the palliative treatment of patients with myeloma for whom oral therapy is not appropriate.

There is a subset of low-risk patients with ductal carcinoma in situ for whom surgery alone is optimal and the Oncotype DX DCIS Score is a useful assay for identifying these individuals.

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.