Jason M. Broderick

Articles

Rituximab Biosimilar Ruxience Approved in Europe

April 2nd 2020

The European Commission has approved the rituximab biosimilar Ruxience for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris

Pembrolizumab Improves PFS in Frontline MSI-H/dMMR Colorectal Cancer

April 2nd 2020

Frontline pembrolizumab significantly improved progression-free survival versus chemotherapy in patients with microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.

Anetumab Ravtansine Shows Promise in Mesothelin-Expressing Solid Tumors

April 2nd 2020

The investigational antibody-drug conjugate anetumab ravtansine showed promising antitumor activity in heavily pretreated patients with mesothelin-expressing solid tumors.

Cancer Vaccine Hits Early Benchmark in NSCLC, But COVID-19 Halts Phase III Trial

April 2nd 2020

OSE-2101 met the primary endpoint in the predefined Step-1 analysis of the phase III Atalante 1 trial in patients with HLA-A2 positive non–small cell lung cancer after failure of anti–PD-1/PD-L1 agents.

FDA Grants Remestemcel-L Priority Review for Pediatric GVHD

April 1st 2020

The FDA has granted remestemcel-L a priority review designation for the treatment of children with steroid-refractory acute graft versus host disease.

Novel Approaches to Build on Checkpoint Inhibition in GI Cancers

April 1st 2020

Despite some success stories, most gastrointestinal cancers do not respond to single-agent, or even double-agent, immune checkpoint inhibition, Neeha Zaidi, MD, said in a presentation during the 5th Annual School of Gastrointestinal Oncology™ (SOGO®) conference.

FDA Grants ME-401 Fast Track Designation for Follicular Lymphoma

April 1st 2020

The FDA has granted ME-401 Fast Track Designation for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

FDA Approval Sought for Tivozanib in Relapsed/Refractory Renal Cell Carcinoma

April 1st 2020

A new drug application has been submitted to the FDA for tivozanib for the treatment of patients with relapsed/refractory renal cell carcinoma, according to Aveo Oncology, the company developing the VEGFR TKI.

Brentuximab Vedotin Approaches European Approval for Frontline ALCL

March 31st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin (Adcetris) for use in combination with chemotherapy for the frontline treatment of adult patients with systemic anaplastic large cell lymphoma.

FDA Approval Sought for Idecabtagene Vicleucel in Multiple Myeloma

March 31st 2020

A biologics license application has been submitted to the FDA for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Darolutamide Approved in Europe for Nonmetastatic CRPC

March 30th 2020

The European Commission has approved darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

Luspatercept Data Published in NEJM Highlight Benefit for Beta Thalassemia-Associated Anemia

March 28th 2020

Results from the pivotal phase III BELIEVE trial, which supported the FDA approval of luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, have been published in the New England Journal of Medicine.

Stereotactic Ablative Radiation Slows Progression in Oligometastatic Prostate Cancer

March 27th 2020

Stereotactic ablative radiation reduced disease progression compared with observation in patients with oligometastatic prostate cancer.

Avapritinib Approval Sought in Taiwan for PDGFRA Exon 18+ GIST

March 27th 2020

A new drug application has been submitted to the Taiwan Food and Drug Administration for avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring PDGFRA exon 18 mutations, including PDGFRA D842V mutations, according to CStone Pharmaceuticals, a partner of Blueprint Medicines.

Isatuximab Nears European Approval for Relapsed/Refractory Myeloma

March 27th 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies.

VB-111 Hits Milestone in Phase III Platinum-Resistant Ovarian Cancer Trial

March 27th 2020

An independent panel determined that the investigational agent VB-111 met the interim prespecified efficacy criterion in the phase III OVAL study in patients with platinum-resistant ovarian cancer, and that the trial should continue without modification.

Melflufen Continues to Impress in Heavily Pretreated Myeloma, FDA Submission Coming Soon

March 26th 2020

Melflufen in continued to show strong clinical activity in patients with triple-class refractory multiple myeloma, according to final topline results from the pivotal phase II HORIZON study.

FDA Grants IPI-549 Fast Track Designation in Urothelial Carcinoma

March 25th 2020

The FDA has granted a Fast Track Designation to IPI-549 for use in combination with nivolumab for the treatment of patients with advanced urothelial cancer, according to Infinity Pharmaceuticals, Inc., the manufacturer of the PI3K-gamma inhibitor.

Trastuzumab Deruxtecan Approved in Japan for HER2+ Metastatic Breast Cancer

March 25th 2020

The Japanese Ministry of Health, Labor, and Welfare has approved trastuzumab deruxtecan for the treatment of patients with HER2-positive unresectable or recurrent breast cancer who have had prior chemotherapy.

Tepotinib Approved in Japan for MET-Positive NSCLC

March 25th 2020

Tepotinib (Tepmetko) has been approved in Japan for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping alterations.