Jason M. Broderick

Articles

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.

FDA Approves FoundationOne CDx as Pemigatinib Companion Diagnostic in FGFR2+ Cholangiocarcinoma

April 21st 2020

The FDA has approved FoundationOne CDx as the registrational companion diagnostic for pemigatinib, which the agency recently approved for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic FGFR2+ cholangiocarcinoma.

COVID-19 Ruxolitinib, Selinexor Trials Officially Begin Enrollment

April 21st 2020

COVID-19 trials exploring the oncology treatments ruxolitinib and selinexor have officially begun patient enrollment.

Nivolumab Plus Ipilimumab Improves Survival in Frontline Mesothelioma

April 20th 2020

Nivolumab combined with ipilimumab significantly improved overall survival versus chemotherapy in previously untreated patients with malignant pleural mesothelioma.

Nivolumab Plus Cabozantinib Improves OS in CheckMate-9ER Frontline RCC Trial

April 20th 2020

Nivolumab combined with cabozantinib improved overall survival and progression-free survival compared with sunitinib in patients with previously untreated advanced renal cell carcinoma.

FDA Grants Surufatinib Fast Track Status in pNETS and Other Neuroendocrine Tumors

April 18th 2020

The FDA has granted Fast Track Designations to surufatinib for the treatment of advanced and progressive pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors in patients who are not amenable for surgery.

RVd Induction Impresses in Myeloma, But 4-Drug Regimens Mark the Future

April 17th 2020

The 3-drug induction regimen of lenalidomide, bortezomib, and dexamethasone led to impressive overall survival outcomes and a very good partial response or better in nearly 90% of patients with newly diagnosed multiple myeloma.

FDA Approves Tucatinib for HER2+ Breast Cancer

April 17th 2020

The FDA has approved tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Acalabrutinib Long-Term Benefit in CLL Captured in Published Data

April 17th 2020

The benefit of single-agent acalabrutinib continued well over 3 years after treatment initiation in patients with relapsed/refractory chronic lymphocytic leukemia.