Jason M. Broderick

Articles

Omidubicel Succeeds in Phase 3 Trial in High-Risk Hematologic Malignancies

May 12th 2020

Omidubicel met the primary end point of time to neutrophil engraftment in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.

Tucatinib Approved in Switzerland for HER2-Positive Breast Cancer

May 12th 2020

Tucatinib has been approved in Switzerland for use in combination with trastuzumab and capecitabine for patients with previously treated metastatic HER2-positive breast cancer.

Isatuximab Plus Carfilzomib/Dexamethasone Improves PFS in Phase 3 Myeloma Trial

May 12th 2020

Adding isatuximab to carfilzomib and dexamethasone improved progression-free survival in patients with relapsed multiple myeloma, meeting the primary end point of the phase 3 IKEMA trial.

FDA Approves myChoice CDx as Companion Diagnostic for Olaparib in Ovarian Cancer

May 11th 2020

The FDA has approved myChoice CDx for use as a companion diagnostic to identify patients with advanced ovarian cancer with positive homologous recombination deficiency status, making them eligible to receive frontline maintenance treatment with olaparib plus bevacizumab.

FDA Approves myChoice CDx as Companion Diagnostic for Olaparib in Ovarian Cancer

May 11th 2020

The FDA has approved myChoice CDx for use as a companion diagnostic to identify patients with advanced ovarian cancer with positive homologous recombination deficiency status, making them eligible to receive frontline maintenance treatment with olaparib plus bevacizumab.

FDA Grants Trastuzumab Deruxtecan Breakthrough Designation in HER2+ Gastric Cancer

May 11th 2020

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Trastuzumab Deruxtecan Breakthrough Designation in HER2+ Gastric Cancer

May 11th 2020

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Approves Selpercatinib for RET+ NSCLC and Thyroid Cancers

May 9th 2020

The FDA has approved selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer.

Antibody-Drug Conjugate STRO-002 Active in Advanced Ovarian Cancer

May 9th 2020

The anti­–folate receptor alpha antibody-drug conjugate STRO-002 showed early clinical promise in patients with advanced ovarian cancer.

FDA Approves Olaparib Plus Bevacizumab as Frontline Maintenance in HRD+ Ovarian Cancer

May 8th 2020

The FDA has approved olaparib plus bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

Vaccine BVAC-C Shows Early Promise in Cervical Cancer

May 8th 2020

The vaccine BVAC-C demonstrated durable antitumor activity in patients recurrent cervical cancer.

Adjuvant Trastuzumab Emtansine Approved in UK for HER2+ Early Breast Cancer

May 7th 2020

Trastuzumab emtansine has been approved in the UK for the adjuvant treatment of patients with HER2-positive early breast cancer.

Trastuzumab Deruxtecan Submitted for Japanese Approval in HER2+ Gastric Cancer

May 7th 2020

A supplemental New Drug Application has been submitted to the Japanese Ministry of Health, Labour and Welfare seeking approval of trastuzumab deruxtecan for the treatment of patients with HER2-positive metastatic gastric cancer

Sintilimab Regimen Improves PFS in Frontline Squamous NSCLC

May 7th 2020

Adding the PD-1 inhibitor sintilimab injection to gemcitabine and platinum-based chemotherapy improved progression-free survival as a frontline treatment in squamous non–small cell lung cancer.

FDA Approves Capmatinib for METex14+ NSCLC

May 6th 2020

The FDA has approved capmatinib for the treatment of patients with non–small cell lung cancer.

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.

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