Jason M. Broderick

Articles

FDA Grants MIV-818 Orphan Drug Status in HCC

May 6th 2020

The FDA has granted an orphan drug designation to MIV-818 for the treatment of patients with hepatocellular carcinoma.

FDA Extends Review Period for Liso-Cel in Large B-Cell Lymphoma

May 6th 2020

The FDA has extended the review period for a biologics license application for lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma.

VERU-111 Shows Promise in mCRPC

May 5th 2020

VERU-111 demonstrated antitumor activity and durable PSA declines in men with metastatic castration-resistant prostate cancer who are resistant to at least 1 novel androgen-blocking agent.

Umbralisib Plus Ublituximab Improves PFS in Frontline and Relapsed/Refractory CLL

May 5th 2020

A doublet combining umbralisib and ublituximab improved progression-free survival in patients with chronic lymphocytic leukemia.

Cemiplimab Shows Strong Activity in Pivotal Basal Cell Carcinoma Trial

May 5th 2020

Cemiplimab induced clinically meaningful and durable responses in patients with advanced basal cell carcinoma.

Nivolumab Plus Regorafenib Regimen Active in Gastrointestinal Cancers

May 5th 2020

The combination of nivolumab and regorafenib demonstrated promising antitumor activity in patients with gastric and colorectal cancer.

FDA Grants HQP1351 Orphan Drug Status in CML

May 4th 2020

The FDA has granted an orphan drug designation to HQP1351 for the treatment of patients with chronic myeloid leukemia.

PARP Inhibitor Trials Revolutionize Frontline Ovarian Cancer

May 4th 2020

Transformative clinical trials of PARP inhibitors have revolutionized the frontline treatment paradigm in advanced ovarian cancer.

FDA Approves Subcutaneous Daratumumab in Multiple Myeloma

May 1st 2020

The FDA has approved a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma.

Encorafenib/Cetuximab Combo Nears EU Approval for BRAF+ mCRC

May 1st 2020

A European panel has recommended approval of encorafenib in combination with cetuximab for the treatment of adult patients with BRAF V600E–mutant metastatic colorectal cancer.

FDA Grants CC-486 Priority Review for Maintenance AML

May 1st 2020

The FDA has granted a priority review designation to CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia.

EU Panel Backs Luspatercept for Anemia in MDS and Beta Thalassemia

May 1st 2020

A European panel has recommended approval of luspatercept for the treatment of anemia in patients with myelodysplastic syndromes and beta thalassemia.

Subcutaneous Daratumumab Nears EU Approval for Multiple Myeloma

May 1st 2020

A European panel has recommended approval of a subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma.

Photodynamic Therapy SGX301 Continues to Impress in Phase 3 CTCL Trial Update

April 30th 2020

Updated data from the pivotal phase 3 FLASH trial showed that SGX301 (synthetic hypericin) continued to demonstrate strong clinical activity in patients with cutaneous T-cell lymphoma.

FDA Approves Niraparib for Frontline Maintenance in Ovarian Cancer

April 29th 2020

The FDA has approved niraparib for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy.

Olaparib Pivotal mCRPC Data Published in NEJM as FDA Weighs Approval

April 29th 2020

Findings from the pivotal phase 3 PROfound trial of olaparib as a treatment for men with metastatic castration-resistant prostate cancer harboring homologous recombination repair (HRR) gene alterations were published in the New England Journal of Medicine.

COVID-19: Practical and Immuno-Oncology Insight in Melanoma and Beyond

April 29th 2020

Paolo A. Ascierto, MD, discussed lessons he has learned from the COVID-19 crisis both in the melanoma treatment paradigm and in the broader immuno-oncology spectrum.

FDA Approves Updated Dosing Schedule for Pembrolizumab

April 29th 2020

The FDA has approved an updated dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg across all indications in adult patients.

Avapritinib Falls Short in VOYAGER Phase 3 GIST Trial

April 28th 2020

Avapritinib did not improve progression-free survival versus regorafenib in previously treated patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor, missing the primary end point of the phase 3 VOYAGER trial.

Subcutaneous Daratumumab Submitted for Japanese Approval in Myeloma

April 28th 2020

A new drug application has been submitted in Japan seeking approval of a subcutaneous formulation of daratumumab.