Jason M. Broderick

Articles

Ivosidenib PFS Benefit in IDH1+ Cholangiocarcinoma Demonstrated in Newly Published Data

May 14th 2020

Ivosidenib induced a 63% reduction in the risk of disease progression or death versus placebo in previously treated patients with IDH1-mutant advanced cholangiocarcinoma, according to findings from the phase 3 ClarIDHy study published in the Lancet Oncology.

Brentuximab Vedotin Approved in Europe for Frontline ALCL

May 14th 2020

The European Commission has approved brentuximab vedotin for use in combination with chemotherapy for the frontline treatment of adult patients with systemic anaplastic large cell lymphoma.

FDA: Idecabtagene Vicleucel Myeloma BLA Needs Further Details

May 13th 2020

The FDA has issued a Refusal to File letter to Bristol Myers Squibb and bluebird bio, Inc., regarding their Biologics License Application (BLA) for the BCMA-directed CAR T-cell therapy decabtagene vicleucel.

FDA: Idecabtagene Vicleucel Myeloma BLA Needs Further Details

May 13th 2020

The FDA has requested additional details before accepting a biologics license application for idecabtagene vicleucel for the treatment of patients with multiple myeloma.

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.

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.

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