Jason M. Broderick

Articles

Niraparib Granted Priority Review in China for Frontline Maintenance in Ovarian Cancer

April 16th 2020

The China National Medical Products Administration has granted a priority review to niraparib for use as a frontline maintenance treatment for adult patients with advanced ovarian cancer.

Pemigatinib Pivotal Cholangiocarcinoma Data Published as FDA Weighs Approval

April 16th 2020

Data from the phase II FIGHT-202 study of pemigatinib in advanced or metastatic FGFR2-positive cholangiocarcinoma have been published as the FDA considers a new drug application for the treatment in this setting.

Trastuzumab Biosimilar Ontruzant Enters US Oncology Market

April 15th 2020

Trastuzumab-dttb (Ontruzant) is now officially available for clinical use in the United States.

Acalabrutinib COVID-19 Trial Launching

April 15th 2020

Acalabrutinib is being explored in the CALAVI trial as a treatment for cytokine storm in patients with COVID-19.

Tislelizumab Frontline Combo Improves PFS in Nonsquamous NSCLC

April 14th 2020

The PD-1 inhibitor tislelizumab combined with frontline chemotherapy significantly improved progression-free survival versus chemotherapy alone in patients with nonsquamous non–small cell lung cancer.

ASCO Launches COVID-19 Cancer Registry, Issues Guidance for Resource Allocation

April 14th 2020

The American Society of Clinical Oncology has been highly proactive in addressing COVID-19–related issues as the pandemic has created a global healthcare crisis.

Adjuvant Osimertinib Succeeds in Phase III ADAURA Trial in EGFR+ NSCLC

April 13th 2020

The phase III ADAURA trial of adjuvant osimertinib in patients with EGFR mutation–positive non–small cell lung cancer has been unblinded due to “overwhelming efficacy.”

Analyses Underscore Extent of Frontline Maintenance Niraparib Benefit in Ovarian Cancer

April 11th 2020

The success of frontline maintenance niraparib in the phase III PRIMA trial extends to meeting biomarker-defined and other secondary endpoints and showing positive patient-reported outcomes.

Gilteritinib Takes Step Toward Chinese Approval for FLT3+ AML

April 10th 2020

The China National Medical Products Administration has accepted an application for gilteritinib for the treatment of adult patients with FLT3 mutation–positive acute myeloid leukemia.

STP705 Shows Promise in Cutaneous Squamous Cell Carcinoma

April 10th 2020

STP705 met the primary efficacy end point in an ongoing phase II study of patients with cutaneous squamous cell carcinoma in situ.

NCCN Publishes COVID-19 Safety Recommendations for Oncology Community

April 9th 2020

The NCCN has published guidelines for ensuring that patients with cancer, care providers, and staff are kept as safe as possible during the COVID-19 crisis.

Avelumab sBLA Filed for Frontline Maintenance in Urothelial Carcinoma, Breakthrough Designation Granted

April 9th 2020

A supplemental Biologics License Application has been filed with the FDA for avelumab for the frontline maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

FDA Approves Encorafenib/Cetuximab Combo for BRAF+ mCRC

April 9th 2020

The FDA has approved the combination of encorafenib and cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, following prior therapy.

Lifirafenib Active in Melanoma, Other Solid Tumors

April 9th 2020

The investigational RAF inhibitor lifirafenib demonstrated antitumor activity in patients with melanoma and other solid tumors.

AV-GBM-1 Active in Frontline Glioblastoma

April 8th 2020

AV-GBM-1 showed early promise in an interim overall survival analysis of an ongoing phase II trial in patients with newly diagnosed glioblastoma.

FDA Grants Nivolumab/Ipilimumab Plus Chemo Priority Review in Frontline NSCLC

April 8th 2020

The FDA has granted a priority review designation to nivolumab plus ipilimumab and chemotherapy for use as a frontline treatment for patients with metastatic or recurrent non–small cell lung cancer.

Paxalisib Shows Positive Survival Data in Glioblastoma

April 8th 2020

Treatment with paxalisib, an investigational small molecule inhibitor of the PI3K/AKT/mTOR pathway, was associated with a positive overall survival signal in patients with glioblastoma.

FDA Grants Balstilimab Fast Track Designation for Cervical Cancer

April 8th 2020

The FDA has granted the PD-1 inhibitor balstilimab a Fast Track Designation for the treatment of patients with cervical cancer.

FDA Grants Sacituzumab Govitecan Fast Track Designation for Urothelial Carcinoma

April 7th 2020

The FDA has granted a fast track designation to sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

Selinexor COVID-19 Global Trial Launching

April 7th 2020

Selinexor, an FDA-approved drug for the treatment of patients with relapsed/refractory multiple myeloma, is being evaluated in a global randomized clinical trial as a potential treatment for hospitalized patients with severe COVID-19.