Jason M. Broderick
Articles
Priority Review Granted by FDA to Dacomitinib for Frontline Treatment in NSCLC
April 5th 2018According to Pfizer, manufacturer of a pan-human EGFR tyrosine kinase inhibitor (TKI), a priority review has been granted by the FDA for their TKI inhibitor, dacomitinib, in the frontline setting for patients with <em>EGFR</em>-positive locally advanced or metastatic non–small cell lung cancer.
Denosumab Granted European Approval for Myeloma
April 3rd 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma
March 20th 2018Based on findings from the phase III ECHELON-1 trial, brentuximab vedotin (Adcetris) has been approved by the FDA for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.
PFS Improved in Frontline Squamous NSCLC with Atezolizumab Plus Chemo
March 20th 2018According to topline findings from the phase III IMpower131 trial, the addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel delayed progression or death compared with chemotherapy alone for patients with advanced squamous non–small cell lung cancer. These results were released by Genentech, the manufacturer of the anti–PD-L1 agent.
Results Show HER2 Mutations Cause Endocrine Resistance in ER+ Breast Cancer
March 19th 2018Uttara Nayar, PhD, shares the findings of recent studies in patients with ER+ breast cancer. Findings have shown that acquired HER2 mutations lead to endocrine resistance, the most frequent cause of breast cancer mortality in the country.
EBRT Shows Promise in Relapsed/Refractory Follicular Lymphoma
March 16th 2018External beam radiation therapy can be effective when integrated in a multimodality treatment strategy for patients with relapsed/refractory follicular lymphoma, according to findings from a small, retrospective study.
MONALEESA-7 Data Shows Ribociclib Active in Premenopausal Breast Cancer Subgroups
March 9th 2018According to results from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference, the progression-free survival benefit for ribociclib in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer had been sustained across patient subgroups.
Sunitinib Not Granted European Panel Support for Approval in High-Risk RCC
March 7th 2018Based on data from the phase III S-TRAC trial,<span style="font-size:10.8333px"> </span>the European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended against approving sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.
Frontline Abemaciclib Granted FDA Approval for HR+/HER2- Breast Cancer
February 27th 2018Based on data from the phase III MONARCH 3 trial, abemaciclib has been granted FDA approval for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.
Updated Findings Show OS Improvement With Binimetinib/Encorafenib in Melanoma as FDA Decision Pends
February 19th 2018In findings from the phase III COLUMBUS trial, the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved survival versus single-agent vemurafenib (Zelboraf) in patients with <em>BRAF</em>-mutant advanced, unresectable or metastatic melanoma.
Durvalumab Granted FDA Approval for Locally Advanced NSCLC
February 17th 2018Based on results from the phase III PACIFIC trial, durvalumab has been granted approval by the FDA for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy.
Apalutamide Receives FDA Approval for Nonmetastatic Castration-Resistant Prostate Cancer
February 15th 2018Based on results of the phase III SPARTAN trial, apalutamide has been approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, making it the first treatment to be approved in this setting.<br />
SPARTAN Trial Demonstrates Significant Delay of Metastasis With Apalutamide in CRPC
February 9th 2018In findings from the phase III SPARTAN trial presented at the 2018 Genitourinary Cancers Symposium and published in the <em>New England Journal of Medicine, </em>apalutamide (Erleada) reduced the risk of metastasis or death by 72% in patients with nonmetastatic castration-resistant prostate cancer.
Duvelisib Submitted for FDA Approval in CLL, Follicular Lymphoma
February 7th 2018Based on supporting data from the phase III DUO trial and the phase II DYNAMO study, duvelisib has been submitted to the FDA for a full approval for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.
Pomalidomide Triplet Therapy Shows Survival Improvement in Relapsed/Refractory Myeloma
February 7th 2018Patients with relapsed/refractory myeloma who had prior exposure to lenalidomide (Revlimid) experienced a significant improvement in progression-free survival with pomalidomide (Pomalyst) added to the combination of bortezomib (Velcade) and low-dose dexamethasone, according to findings from the phase III OPTIMISMM trial.
FDA Grants Approval to Carfilzomib Label Update in Myeloma
January 18th 2018The FDA has issued its approval for overall survival data from the phase III ENDEAVOR trial to be added to the carfilzomib (Kyprolis) label for use in patients with relapsed or refractory multiple myeloma.
Tisagenlecleucel Granted Priority Review by FDA for DLBCL
January 17th 2018Based on results of the phase II JULIET study, a supplemental biologics license application for the CAR T-cell therapy tisagenlecleucel (Kymriah) has been granted a priority review by the FDA as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.
Pembrolizumab Receives Approval in Japan for Urothelial Carcinoma
January 9th 2018Pembrolizumab (Keytruda) has been approved in Japan for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.
Pembrolizumab/Lenvatinib Combo Granted FDA's Breakthrough Therapy Designation for RCC
January 9th 2018Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
Denosumab Granted FDA Approval for Multiple Myeloma
January 5th 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Ribociclib Granted Breakthrough Therapy Designation by FDA for HR+/HER2- Premenopausal Breast Cancer
January 3rd 2018Based on results of the phase III MONALEESA-7 trial, ribociclib (Kisqali) has been granted a breakthrough therapy designation by the FDA for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
Frontline Brentuximab Vedotin Receives FDA's Priority Review for Hodgkin Lymphoma
January 3rd 2018Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
Adjuvant Dabrafenib/Trametinib Granted Priority Review by FDA for BRAF+ Melanoma
December 22nd 2017Based on findings of the phase III COMBI-AD study, a supplemental new drug application for dabrafenib (Tafinlar) combined with trametinib (Mekinist) has been granted a priority review by the FDA as an adjuvant treatment for patients with <em>BRAF</em> V600E– or V600K–positive stage III melanoma following complete resection.
Frontline Avelumab/Axitinib Combo Receives FDA's Breakthrough Designation for RCC
December 22nd 2017The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma.
