Jason M. Broderick

CPX-351 (Vyxeos) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

Clovis has stopped clinical development of rociletinib, its once promising EGFR inhibitor for the treatment of patients with EGFR T790M-mutated non-small cell lung cancer (NSCLC).

Second-line treatment with regorafenib improved overall survival compared with best supportive care for patients with unresectable hepatocellular carcinoma following progression on sorafenib.

The FDA has granted an biologics license application for olaratumab a priority review for use in combination with doxorubicin as a 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 a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Given the numerous available treatment options, the most important issue in frontline colorectal cancer (CRC) care is clarifying the goals of therapy, according to Wells Messersmith, MD.

The FDA has approved afatinib for the treatment of patients with advanced squamous cell non-small cell lung cancer following progression on platinum-based chemotherapy.

The FDA has granted nivolumab (Opdivo) a priority review for use in previously treated patients with classical Hodgkin lymphoma (cHL), giving the drug the potential to become the first PD-1 inhibitor approved for a hematologic malignancy.

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib for patients with metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) who have previously received an EGFR-targeted 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 (NSCLC) who express PD-L1 and have progressed after a platinum-containing regimen.

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.

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.

Patients with advanced ovarian cancer harboring mutations in homologous recombination (HR) genes, including BRCA1/2, had improved survival versus patients without HR mutations, according to a mutational analysis of the phase III GOG 218 study.

Ibrutinib (Imbruvica) has been approved by the FDA as a frontline treatment for patients with chronic lymphocytic leukemia (CLL), based on data from the phase III RESONATE-2 trial.

The FDA has received a supplemental biologics license application to expand the approval of blinatumomab to include pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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

Blinatumomab (Blincyto), an anti-CD19 agent, had a 69% response rate in patients with non-Hodgkin Lymphoma (NHL), according to updated data from a phase I, open-label, multicenter study.

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

Patients with advanced non-small cell lung cancer receiving the combination checkpoint blockade with the PD-L1 inhibitor durvalumab and the anti-CTLA-4 agent tremelimumab had a response rate of 23%, according to phase Ib data from Study 006.

The FDA has granted an affinity enhanced T-cell therapy breakthrough therapy designation for 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

The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.

Single-dose fosaprepitant dimeglumine (Emend for injection) in combination with antiemetic agents has been approved by the FDA for the preventing

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

The FDA has granted breakthrough therapy designation to Venetoclax combined with hypomethylating agents in patients with treatment-naive acute myeloid leukemia (AML) who are not eligible for standard high-dose induction treatment, according to AbbVie, which is codeveloping the BCL-2 inhibitor with Genentech.

Nivolumab (Opdivo) produced an overall response rate (ORR) of 14% with an acceptable safety profile in patients with gastric or gastroesophageal junction (GEJ) cancer, according to data from the phase I/II CheckMate-032 trial.

The frontline melanoma indications for nivolumab (Opdivo), as both a single agent and in combination with ipilimumab (Yervoy), have been expanded by the FDA to include patients with BRAF V600 mutations. This expansion was based on data from the phase III CheckMate-067 trial.

Carfilzomib (Kyprolis) has been approved by the FDA in combination with either dexamethasone or lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy. The approval is based on findings from the phase III ENDEAVOR trial.

The FDA has designated the BCL-2 inhibitor venetoclax as a breakthrough therapy for use in combination with rituximab (Rituxan) to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

Patients with either gastrointestinal (GI) neuroendocrine tumors (NETs) or NETs of unknown primary origin experienced a 40% or more decrease in their risk of disease progression when treated with everolimus (Afinitor), according to a subanalysis of the phase III RADIANT-4 trial.

Ofatumumab (Arzerra) has received FDA approved for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia (CLL). Patients eligible to receive the treatment must show complete or partial response following at least two lines of therapy.