Jason M. Broderick

Articles

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.

FDA Grants Pembrolizumab Priority Review for TMB-High Tumors

April 7th 2020

The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high status.

Leronlimab COVID-19 Trial Treats First Patients

April 7th 2020

The first 2 patients with COVID-19 have received treatment in a phase II trial exploring the investigational agent leronlimab, a CCR5 antagonist which has been advancing through the pipeline as a treatment for patients with triple-negative breast cancer.

Analysis Pinpoints Veliparib Antitumor Activity in Ovarian Cancer

April 6th 2020

Adding veliparib to frontline induction chemotherapy increased complete and CA-125 responses compared with chemotherapy alone in patients with high-grade serous ovarian cancer, according to an exploratory analysis of the phase III VELIA trial.

Brigatinib Approved in Europe for Frontline ALK+ NSCLC

April 6th 2020

The European Commission has approved brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer.

Sacituzumab Govitecan Succeeds in Phase III TNBC Trial, as FDA Weighs Approval

April 6th 2020

Positive efficacy data have halted the confirmatory phase III ASCENT study exploring sacituzumab govitecan in patients with metastatic triple-negative breast cancer.

KTE-X19 Pivotal MCL Data Published in NEJM as FDA Weighs Approval

April 4th 2020

Findings from the pivotal phase II ZUMA-2 trial of KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma were published in the New England Journal of Medicine, as the FDA considers a biologics license application for the CAR T-cell therapy for an approval in this setting.

FDA Approval Sought for Naxitamab in Neuroblastoma

April 4th 2020

A Biologics License Application has been filed with the FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

Tocilizumab Successfully Treats COVID-19 in Patient With Myeloma

April 4th 2020

The oncology supportive care agent tocilizumab might effectively treat cytokine storm caused by COVID-19 in patients with blood cancers, according to a case study of a patient with multiple myeloma.

FDA Approves Luspatercept for MDS-Associated Anemia

April 4th 2020

The FDA has approved luspatercept for the treatment of anemia in patients with myelodysplastic syndromes.

UGN-102 Active in Non-Muscle Invasive Bladder Cancer

April 3rd 2020

UGN-102 for intravesical solution induced a 65% complete response rate in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.

Ruxolitinib Phase III Trial Launching for COVID-19 Complications

April 3rd 2020

The oncology drug ruxolitinib is being explored in the planned phase III RUXCOVID trial as a treatment for cytokine storm in patients with COVID-19.

Navicixizumab Combo Shows Benefit in Heavily Pretreated Ovarian Cancer

April 3rd 2020

The anti-DLL4/VEGF bispecific antibody navicixizumab showed promising clinical activity when used in combination with paclitaxel in heavily pretreated patients with platinum-resistant ovarian cancer.