Jason M. Broderick

Articles

FDA Approves Updated Dosing Schedule for Pembrolizumab

April 29th 2020

The FDA has approved an updated dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg across all indications in adult patients.

Avapritinib Falls Short in VOYAGER Phase 3 GIST Trial

April 28th 2020

Avapritinib did not improve progression-free survival versus regorafenib in previously treated patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor, missing the primary end point of the phase 3 VOYAGER trial.

Subcutaneous Daratumumab Submitted for Japanese Approval in Myeloma

April 28th 2020

A new drug application has been submitted in Japan seeking approval of a subcutaneous formulation of daratumumab.

Pacritinib COVID-19 Trial Launched

April 28th 2020

Pacritinib is being explored in the phase 3 PRE-VENT trial as a treatment for cytokine storm in hospitalized patients with severe COVID-19.

Continuous Dabrafenib/Trametinib Dosing Improves PFS in BRAF+ Melanoma

April 27th 2020

Continuous dosing with dabrafenib and trametinib improved progression-free survival compared with intermittent dosing in patients with BRAF mutation–positive advanced melanoma.

FDA Grants Mobocertinib Breakthrough Designation for EGFR Exon 20–Mutant NSCLC

April 27th 2020

Mobocertinib (TAK-788) has received an FDA breakthrough therapy designation for the treatment of patients with EGFR exon 20-mutant non–small cell lung cancer.

Cemiplimab Improves Survival in Frontline PD-L1–High NSCLC

April 27th 2020

The PD-1 inhibitor cemiplimab significantly improved overall survival as a frontline treatment for patients with high–PD-L1 non–small cell lung cancer.

Dostarlimab Active in dMMR Endometrial Cancer

April 25th 2020

The PD-1 inhibitor dostarlimab demonstrated clinically meaningful activity in patients with mismatch repair–deficient endometrial cancer.

Sintilimab Plus Pemetrexed Frontline NSCLC Application Accepted in China

April 24th 2020

The National Medical Products Administration of China has accepted an application for the PD-1 inhibitor sintilimab injection for use in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Olaparib Improves Survival in HRR-Mutant mCRPC

April 24th 2020

Olaparib improved overall survival in previously treated patients with metastatic castration-resistant prostate cancer harboring homologous recombination repair gene mutations.

Avapritinib Takes Step Toward Chinese Approval for GIST

April 23rd 2020

The China National Medical Products Administration has accepted a new drug application for avapritinib for 2 indications in gastrointestinal stromal tumors.

Neratinib Global Access Expands for HER2+ Breast Cancer

April 23rd 2020

Global access to neratinib has increased with the drug now being made commercially available in Singapore.

Pembrolizumab FDA Applications Resubmitted for Updated Dosing Schedule

April 23rd 2020

Supplemental biologics license applications have been resubmitted to the FDA for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions across multiple indications.

Ruxolitinib REACH2 aGVHD Data Show Superiority Over Standard Care

April 23rd 2020

The REACH2 ruxolitinib acute graft-versus-host disease data have been published in the New England Journal of Medicine.

Larotrectinib Approved in UK for NTRK+ Cancers

April 22nd 2020

The United Kingdom’s National Institute for Health and Care Excellence has recommended larotrectinib for the treatment of adult and pediatric patients with advanced NTRK fusion–positive solid tumors.

FDA Approves Sacituzumab Govitecan for TNBC

April 22nd 2020

The FDA has granted an accelerated approval to the antibody-drug conjugate sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer.

FDA Grants RMAT Designation to Tisagenlecleucel for Follicular Lymphoma

April 22nd 2020

The FDA has granted a Regenerative Medicine Advanced Therapy designation to tisagenlecleucel for the treatment of patients with relapsed/refractory follicular lymphoma.

Tislelizumab Frontline Combo Takes Step Toward Chinese Approval in Squamous NSCLC

April 21st 2020

The China National Medical Products Administration has accepted a supplemental new drug application for the PD-1 inhibitor tislelizumab for use in combination with chemotherapy for the first-line treatment of patients with advanced squamous non–small cell lung cancer.

FDA Approves New Use for cobas HPV Cervical Cancer Screening Test

April 21st 2020

The cobas HPV test for cervical cancer screening is now FDA-approved for use on the high-throughput cobas 6800/8800 Systems.

FDA Approval Sought for Relugolix in Prostate Cancer

April 21st 2020

A New Drug Application has been submitted to the FDA for single-agent relugolix for use as a treatment for men with advanced prostate cancer.