News

The FDA has approved Cologuard as the first noninvasive stool-based DNA test for the detection of CRC in asymptomatic individuals at average risk, based on clinical trial results demonstrating superiority to the fecal immunochemical test.

The FDA has expanded the bortezomib (Velcade) label to allow for retreatment in patients with multiple myeloma who previously responded to the proteasome inhibitor.

AstraZeneca has announced new collaborations with QIAGEN and Roche to create 2 separate, noninvasive companion diagnostic tests to be used with 2 of its drugs for NSCLC, gefitinib (IRESSA) and AZD9291.

Women harboring a loss-of-function mutation in the PALB2 gene demonstrated an increased risk of developing breast cancer that was similar to the predisposition seen with mutations in BRCA.

The FDA has assigned a priority review designation to the JAK1/2 inhibitor ruxolitinib as treatment for patients with polycythemia vera who are resistant or intolerant to hydroxyurea.

The combination of carfilzomib, carfilzomib, and low-dose dexamethasone extended PFS by 8.7 months compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma.

Last week, the US Food and Drug Administration (FDA) announced two steps it will take to ensure the safety and utility of certain diagnostic tests.

The FDA has expanded the approval of ibrutinib (Imbruvica) to include the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy and harbor a 17p deletion.

A phase III trial analyzing sorafenib for the treatment of patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

This activity is supported by an educational grant from Eisai, Inc.

The FDA has assigned a priority review designation to bevacizumab (Avastin) in combination with chemotherapy for patients with recurrent platinum-resistant ovarian cancer.

The somatostatin analog lanreotide (Somatuline Depot) significantly prolonged progression-free survival (PFS) compared with placebo for patients with metastatic gastroenteropancreatic NETs.

The FDA has assigned a priority review designation to bevacizumab (Avastin) plus chemotherapy as a treatment for patients with persistent, recurrent, or metastatic cervical cancer.

A phase III study comparing trametinib (Mekinist) plus dabrafenib (Tafinlar) with single-agent vemurafenib (Zelboraf) has been stopped early following a positive interim analysis.

The combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib significantly improved progression-free survival (PFS) compared with vemurafenib alone for patients with untreated BRAFV600-mutated advanced melanoma.

The investigational CD19-targeted chimeric antigen receptor (CAR) therapy CTL019 has received a breakthrough therapy designation from the FDA as a potential treatment for pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL).

The PD-1 inhibitor nivolumab and the second-generation ALK inhibitor alectinib have each gained their first approvals as treatments for patients in Japan.

The FDA has approved the novel pan-HDAC inhibitor belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

The FDA has granted a breakthrough therapy designation to blinatumomab for the treatment of adult patients with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

For the prevention of nausea and vomiting after the first day of cisplatin-based chemotherapy, both aprepitant and metoclopramide when used in combination with dexamethasone were found to be similarly effective.

Four independent prognostic factors for improved overall survival (OS) in patients with locally advanced pancreatic cancer (LAPC) emerged from an analysis of the LAP 07 phase III trial.

The FDA’s ODAC voted 11-2 against the accelerated approval of the PARP inhibitor olaparib as a maintenance therapy for women with platinum-sensitive relapsed ovarian cancer with germline BRCA mutations.

Frontline treatment with the anti-PD-1 agent nivolumab significantly extended overall survival (OS) when compared with dacarbazine for patients with metastatic or unresectable melanoma.

Triple-negative breast cancer (TNBC) accounts for only 15% to 20% of breast cancers in the US.

Continuing EGFR inhibition beyond progression with afatinib (Gilotrif) plus paclitaxel significantly improved PFS and ORR compared with chemotherapy alone in patients with heavily pretreated metastatic NSCLC.

This activity is designed to educate oncologists and oncology nurses on evolving strategies for management of early-stage and metastatic triple-negative breast cancer.

The FDA has approved gadobutrol (Gadavist) injection for intravenous use with breast MRI to detect and identify the extent of disease.