Jason M. Broderick

Articles

Isatuximab Approved in Europe for Relapsed/Refractory Myeloma

June 2nd 2020

The European Commission has approved isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies.

Melflufen Continues Advance Through Myeloma Pipeline

June 2nd 2020

An update on the phase 3 OCEAN study of melflufen in relapsed/refractory multiple myeloma reported that patients stayed on treatment longer than had been previously estimated.

Olaparib Approaches EU Approval for Frontline Maintenance in Pancreatic Cancer

June 1st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.

Palbociclib Falls Short in Phase 3 Early Breast Cancer Trial

June 1st 2020

The phase 3 PALLAS trial exploring palbociclib (Ibrance) in patients with HR-positive, HER2-negative early breast cancer is unlikely to demonstrate a statistically significant improvement in the study’s primary end point of invasive disease-free survival.

EU Panel Backs Entrectinib for NTRK+ Tumors and ROS1+ NSCLC

June 1st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non–small cell lung cancer not previously treated with ROS1 inhibitors.

Alpelisib Nears EU Approval for PIK3CA+ Breast Cancer

June 1st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the PI3K inhibitor alpelisib for use in combination with fulvestrant as treatment for patients with breast cancer.

Cabozantinib Plus Atezolizumab Shows Promise in mCRPC

May 31st 2020

The combination of cabozantinib and atezolizumab showed clinically meaningful activity in patients with metastatic castration-resistant prostate cancer.

Tislelizumab Frontline Combos Extend PFS in Squamous NSCLC

May 31st 2020

Combining the anti–PD-1 agent tislelizumab with chemotherapy improved progression-free survival compared with chemotherapy alone as a frontline treatment in Chinese patients with advanced squamous non–small cell lung cancer.

Update Sustains OS Benefit With Encorafenib/Cetuximab Regimens in BRAF+ mCRC

May 30th 2020

The latest results from the phase 3 BEACON CRC study continued to show an overall survival benefit for encorafenib plus cetuximab with or without binimetinib compared with cetuximab plus irinotecan-containing regimens in patients with BRAF V600E–mutated metastatic colorectal cancer.

FDA Approves Ramucirumab Plus Erlotinib for Frontline EGFR+ NSCLC

May 30th 2020

The FDA has approved the combination of ramucirumab and erlotinib as a frontline treatment for patients with metastatic non–small cell lung cancer whose tumors harbor EGFR mutations.

Idecabtagene Vicleucel Highly Active in Heavily Pretreated Myeloma

May 30th 2020

Idecabtagene vicleucel induced a response in nearly three-fourths of patients with heavily pretreated relapsed/refractory multiple myeloma, according to topline findings from the pivotal phase 2 KarMMA trial.

FDA Approves Atezolizumab Plus Bevacizumab for Frontline HCC

May 29th 2020

The FDA has approved atezolizumab plus bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Alpelisib Impresses in PIK3CA+ Breast Cancer After Progression on CDK Inhibition

May 29th 2020

Over half of patients with PIK3CA-positive, HR-positive/HER2-negative advanced breast cancer who had prior treatment with a CDK4/6 inhibitor plus an aromatase inhibitor were alive without disease progression 6 months after starting treatment with alpelisib plus fulvestrant.

Avelumab Extends Survival as Frontline Maintenance in Urothelial Carcinoma

May 29th 2020

Adding avelumab to best supportive care improved the median overall survival by over 7 months in patients with locally advanced or metastatic urothelial carcinoma, according to findings from the phase 3 JAVELIN Bladder 100 study.

Maintenance Niraparib Boosts PFS in Phase 3 Study of Chinese Patients With Ovarian Cancer

May 29th 2020

Maintenance niraparib improved progression-free survival in Chinese patients with recurrent ovarian cancer who were in a complete or partial response to platinum-based chemotherapy, meeting the primary end point of the phase 3 NORA study.

NCCN Adds Rucaparib to Prostate Cancer Guidelines

May 28th 2020

The National Comprehensive Cancer Network has updated its Prostate Cancer guidelines to include the PARP inhibitor rucaparib.

FDA Grants Onvansertib Fast Track Designation in KRAS+ mCRC

May 28th 2020

The FDA has granted Fast Track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

FDA Waives ODAC Review of Margetuximab in HER2+ Breast Cancer

May 28th 2020

The FDA’s Oncologic Drugs Advisory Committee will no longer be meeting to review a Biologics License Application for margetuximab for the treatment of patients with HER2-positive breast cancer.

Atezolizumab Combo Approved in UK for Small Cell Lung Cancer

May 28th 2020

Atezolizumab in combination with carboplatin and etoposide has been approved in the UK for the frontline treatment of patients with extensive-stage small cell lung cancer.

FDA Approves Nivolumab/Ipilimumab Plus Chemo for Frontline NSCLC

May 27th 2020

The FDA has approved nivolumab combined with ipilimumab and chemotherapy for use as a frontline treatment for patients with metastatic or recurrent non–small cell lung cancer.