Jason M Broderick


Investigational Therapy Significantly Improves Survival in Patients with Prostate Cancer

June 04, 2021

The addition of an investigational therapy to standard-of-care treatment was associated with a median overall survival of 15.3 months in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.

FDA Grants Polivy Accelerated Approval for DLBCL

June 10, 2019

The FDA has granted an accelerated approval to Polivy for use in combination with bendamustine and Rituxan for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma who have received at least two prior therapies.

FDA Approves Piqray to Treat Breast Cancer

May 25, 2019

The Food and Drug Administration has approved the PI3K inhibitor Piqray (alpelisib) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

Immunotherapy Regimen Granted Priority Review in Small Cell Lung Cancer

December 05, 2018

The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for Tecentriq (atezolizumab) for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

FDA Approves Larotrectinib for NTRK-Positive Cancers

November 27, 2018

The FDA has granted an accelerated approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

FDA Grants Lynparza Priority Review for Frontline Maintenance in Ovarian Cancer

November 12, 2018

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for Lynparza (olaparib) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

FDA Approves Empliciti Regimen to Treat Relapsed or Refractory Myeloma

November 07, 2018

The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.

Drug Duo Granted Priority Review for CLL Treatment

October 17, 2018

The FDA has granted a priority designation to a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) for use in combination with Gazyva (obinutuzumab) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

FDA Approves Vizimpro for EGFR-Positive Lung Cancer

September 28, 2018

The Food and Drug Administration (FDA) has approved Vizimpro (dacomitinib) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations, according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI).

FDA Grants Empliciti Combination a Priority Review for Myeloma Treatment

August 23, 2018

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor (PI).

FDA Grants Full Approval for Keytruda Combination in Lung Cancer

August 20, 2018

The Food and Drug Administration (FDA) has granted a full approval to frontline Keytruda (pembrolizumab) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), based on findings from the phase 3 KEYNOTE-189 trial.

Triplet Gets Breakthrough Therapy Designation in Colorectal Cancer

August 08, 2018

The FDA has granted a breakthrough therapy designation to the combination of the BRAF inhibitor Braftovi (encorafenib), the MEK inhibitor Mektovi (binimetinib), and the EGFR inhibitor Erbitux (cetuximab) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC) following one or two prior lines of treatment in the metastatic setting.

Drug Duo Granted Breakthrough Status to Treat Endometrial Cancer

August 02, 2018

The FDA has granted a breakthrough therapy designation to the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after at least one prior systemic therapy.

FDA Approves Azedra for Rare Neuroendocrine Tumors

July 31, 2018

The Food and Drug Administration (FDA) has approved Azedra (iobenguane I-131) for adult and pediatric patients aged 12 years or older with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.

FDA Approves Drug Duo for BRAF-Positive Melanoma

June 27, 2018

The FDA has approved the combination of the BRAF inhibitor Braftovi (encorafenib) and the MEK inhibitor Mektovi (binimetinib) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.

Keytruda Granted sBLA for Melanoma Treatment

June 25, 2018

The FDA has accepted a supplemental biologics license application (sBLA) for the use of Keytruda (pembrolizumab) as an adjuvant treatment for patients with resected, high-risk stage 3 melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor.

Drug Duo Granted Priority Review to Treat Waldenstrom Macroglobulinemia

June 25, 2018

The FDA has granted a priority review to a supplemental new drug application (sNDA) Imbruvica (ibrutinib) for use in combination with Rituxan (rituximab) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

FDA Grants Gilteritinib a Priority Review for Acute Myeloid Leukemia Treatment

May 29, 2018

The Food and Drug Administration (FDA) has granted a priority review to a new drug application (NDA) for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML), according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.