OncLive Staff

Articles

Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer

April 30th 2019

The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of talazoparib (Talzenna) for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2 mutations.

Encorafenib/Binimetinib-based Triplet Added to NCCN Guidelines for BRAF+ CRC

March 18th 2019

The NCCN has updated their clinical practice guidelines for the treatment of patients with colorectal cancer to include the regimen of encorafenib and binimetinib plus EGFR inhibition with either cetuximab or panitumumab as a Category 2a treatment recommendation for patients with BRAF V600E–mutant metastatic colorectal cancer, after failure of 1 or 2 lines of therapy for metastatic disease.

FDA Approves Atezolizumab Combo for Frontline TNBC

March 8th 2019

The FDA has approved the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

FDA Approval Sought for Darolutamide for Nonmetastatic CRPC

February 27th 2019

A new drug application has been filed with the FDA for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

Frontline Olaparib Maintenance Improves PFS in BRCA+ Pancreatic Cancer

February 26th 2019

Frontline maintenance therapy with olaparib significantly reduced the risk of disease progression or death versus placebo in patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas, according to findings from the phase III POLO trial.

Subcutaneous Daratumumab Succeeds in Phase III Myeloma Trial

February 26th 2019

A subcutaneous formulation of daratumumab is noninferior in inefficacy and pharmacokinetics compared with standard intravenous daratumumab in patients with relapsed/refractory multiple myeloma.

Avelumab Falls Short in Frontline Ovarian Cancer Trial

December 26th 2018

The phase III JAVELIN Ovarian 100 study exploring frontline avelumab in ovarian cancer has been ended after an independent panel determined the study would not meet its primary endpoint of progression-free survival.

FDA Approves Romiplostim for Pediatric ITP

December 15th 2018

The FDA has approved romiplostim for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Tivozanib Improves PFS in Highly Refractory RCC

November 6th 2018

The VEGF inhibitor tivozanib reduced the risk of disease progression or death by 26% compared with sorafenib in patients with highly refractory advanced or metastatic RCC, according to topline findings from the phase III TIVO-3 trial.

Venetoclax Plus Obinutuzumab Improves PFS in Frontline CLL

November 1st 2018

The combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) reduced the risk of disease progression or death versus obinutuzumab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia with comorbidities.

FDA Grants Priority Review to TAS-102 for Gastric/GEJ Cancer

October 26th 2018

The FDA has granted a priority review to a supplemental new drug application for TAS-102 for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.

Pembrolizumab/Axitinib Improves Survival in Frontline RCC

October 19th 2018

Combining the PD-1 inhibitor pembrolizumab with the VEGF inhibitor axitinib significantly improved survival versus sunitinib as a first-line treatment for patients with advanced or metastatic renal cell carcinoma.

FDA Approves Gardasil 9 HPV Vaccine for Use Up to Age 45

October 7th 2018

The HPV vaccine Gardasil 9 is now approved by the FDA for use in males and females aged 9 through 45 years.

FDA Grants Selinexor Priority Review for Multiple Myeloma

October 7th 2018

The FDA has granted a priority review to a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma.

IDO Inhibitors Emerging as New Players on Checkpoint Blockade Scene

August 15th 2017

As researchers continue to explore immune checkpoints as targets for anticancer therapies, the IDO pathway has emerged as the leading contender to yield the next batch of new drugs in the field.