Jason M. Broderick

Articles

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.

ASCO Meeting Goes Virtual Due to COVID-19

March 24th 2020

Due to COVID-19, the ASCO Annual Meeting will now occur using a virtual format.

FDA Approves New Dose of Trastuzumab Biosimilar Ontruzant

March 24th 2020

The FDA has approved a 420-mg multidose vial of the biosimilar trastuzumab-dttb (SB3; Ontruzant).

FDA OKs Launch of Phase III Tocilizumab Trial for COVID-19 Pneumonia

March 23rd 2020

The FDA has approved the initiation of a double-blind, randomized phase III clinical trial of the oncology supportive care drug tocilizumab for use in combination with standard of care for the treatment of hospitalized adult patients with severe COVID-19 pneumonia.

Venetoclax Combo Improves Survival in Frontline AML

March 23rd 2020

Venetoclax combined with azacitidine improved overall survival versus azacitidine alone in patients with previously untreated acute myeloid leukemia.

ASCO Speaks Out on COVID-19

March 21st 2020

Experts from ASCO detail the organization's response to the COVID-19 crisis and resources available for its members.

Oncology Supportive Care Drug Explored as Treatment for COVID-19 Pneumonia

March 20th 2020

Tocilizumab, a treatment used for adverse events related to cancer therapy, among other indications, is being explored in a phase III trial as a treatment for adult patients hospitalized with severe COVID-19 pneumonia, according to Genentech (Roche), the manufacturer of the interleukin-6 receptor antagonist.

Olaparib Takes Key Regulatory Step Toward Japanese Approval in Pancreatic Cancer

March 19th 2020

Olaparib has received an orphan drug designation in Japan for the maintenance treatment of germline BRCA-mutated curatively unresectable pancreatic cancer.

Photodynamic Therapy SGX301 Shows Significant Response in Pivotal Phase III CTCL Trial

March 19th 2020

Topline results from the pivotal phase III FLASH trial showed that SGX301 demonstrated strong clinical activity in patients with cutaneous T-cell lymphoma.

Almonertinib Approved in China for EGFR T79M+ NSCLC

March 19th 2020

The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.

FDA Grants ALPN-101 Orphan Drug Designations in GVHD

March 18th 2020

The FDA has granted 2 Orphan Drug Designations to ALPN-101 for the prevention and treatment of acute graft-versus-host-disease.

Durvalumab/Chemo OS Benefit Sustained in ES-SCLC, But Durvalumab/Tremelimumab Regimen Falls Short

March 17th 2020

Combining durvalumab with standard frontline chemotherapies showed a sustained overall survival benefit in patients with extensive-stage small cell lung cancer, but a regimen of durvalumab, chemotherapy, and tremelimumab did not boost OS.

Case Series Shows Feasibility of Haploidentical Transplant in High-Risk Myelofibrosis

March 17th 2020

Haploidentical allogeneic stem cell transplant is a viable treatment option for patients with myelofibrosis who have a higher risk for posttransplant complications and mortality.

Niraparib Takes Step Toward Chinese Approval for Frontline Maintenance in Ovarian Cancer

March 16th 2020

The China National Medical Products Administration has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Frontline Avelumab Falls Short in Phase III Head and Neck Cancer Study

March 13th 2020

The phase III JAVELIN Head and Neck 100 trial has been terminated after an interim analysis showed that the addition of avelumab to standard-of-care chemoradiotherapy was unlikely to lead to a statistically significant improvement in progression-free survival in patients with untreated locally advanced squamous cell carcinoma of the head and neck.

FDA Grants Balstilimab/Zalifrelimab Dual Immunotherapy Fast Track Designation in Cervical Cancer

March 13th 2020

The FDA has granted a Fast Track designation to the combination of the PD-1 inhibitor balstilimab and the CTLA-inhibitor zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer.

FDA Approves Cytology Test to Enhance Cervical Cancer Prevention

March 11th 2020

The FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.

Adjuvant Chemotherapy Shows Strong Benefit in Upper Tract Urothelial Carcinoma

March 7th 2020

Adjuvant platinum-based chemotherapy reduced the risk of disease recurrence or death by 55% in patients with upper tract urothelial carcinoma, according to findings from the phase III POUT trial that have now been published in The Lancet.