Jason M. Broderick

Articles

Belumosudil Impresses in cGVHD, FDA Submission Started

May 21st 2020

Belumosudil (KD025) continued to show high levels of clinical activity in patients with previously treated chronic graft-versus-host disease.

Selinexor sNDA Submitted to FDA for Earlier Use in Multiple Myeloma

May 20th 2020

A supplemental New Drug Application has been submitted to the FDA for the use of selinexor as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

FDA Approves Multiple Companion Diagnostics for Olaparib in HRR+ mCRPC

May 20th 2020

The FDA has approved two companion diagnostics to identify patients with metastatic castration-resistant prostate cancer with homologous recombination repair mutations, making them eligible for treatment with olaparib.

Selinexor sNDA Submitted to FDA for Earlier Use in Multiple Myeloma

May 20th 2020

A supplemental New Drug Application has been submitted to the FDA for the use of selinexor as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

FDA Approves Olaparib for HRR-Mutant mCRPC

May 20th 2020

The FDA has approved olaparib for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone acetate.

Immunotherapy-Based Triplet Highly Active in Frontline HER2+ Esophagogastric Cancer

May 19th 2020

Pembrolizumab combined with trastuzumab and chemotherapy demonstrated promising clinical activity in patients with HER2-positive metastatic esophagogastric cancer.

FDA Approves PD-L1 IHC 28-8 pharmDx as Companion Diagnostic for Nivolumab Plus Ipilimumab in NSCLC

May 18th 2020

The FDA has approved PD-L1 IHC 28-8 pharmDx for use as a companion diagnostic to identify patients with metastatic non–small cell lung cancer with PD-L1 tumor expression ≥1%, making them eligible for frontline treatment with nivolumab plus ipilimumab.

FDA Grants Trastuzumab Deruxtecan Breakthrough Designation for HER2+ NSCLC

May 18th 2020

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive metastatic non–small cell lung cancer.

FDA Grants Trastuzumab Deruxtecan Breakthrough Designation for HER2+ NSCLC

May 18th 2020

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive metastatic non–small cell lung cancer.

FDA Approves Ripretinib for Advanced GIST

May 16th 2020

The FDA has approved ripretinib (Qinlock) for the fourth-line treatment of patients with advanced gastrointestinal stromal tumor.

FDA Approves Nivolumab/Ipilimumab for Frontline Advanced PD-L1+ NSCLC

May 15th 2020

The FDA has approved the combination of nivolumab and ipilimumab for the first-line treatment of patients with PD-L1–positive metastatic or recurrent non–small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.

FDA Approves Rucaparib for BRCA+ mCRPC

May 15th 2020

The FDA has approved rucaparib for the treatment of adult patients with BRCA-mutant recurrent, metastatic castration-resistant prostate cancer.

FDA Approves Pomalidomide for Kaposi Sarcoma

May 15th 2020

The FDA has approved pomalidomide for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative.

FDA Issues Complete Response Letter for Avapritinib in Fourth-Line GIST

May 15th 2020

The FDA issued a complete response letter stating it will not approve an application for avapritinib for the fourth-line treatment of patients with gastrointestinal stromal tumor. 

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

May 15th 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.

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.

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