Telotristat ethyl has been approved by the FDA for use in combination with somatostatin analog as a treatment for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.
Jason M. Broderick
Articles by Jason M. Broderick
A biologics license application for avelumab has been granted a priority review by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
Ceritinib has been granted a priority review by the FDA as a first-line treatment for patients with <em>ALK</em>-positive, metastatic NSCLC.
Lenalidomide has been approved by the FDA as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant.
A full regulatory approval is being sought for blinatumomab as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor ALL.
A supplemental Biologics License Application for pembrolizumab has been granted a priority review by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who progress following platinum-containing chemotherapy.
Based on data from 2 phase III trials, the EMA’s CHMP has recommended approval of lenalidomide as a maintenance therapy following autologous stem cell transplant for patients with newly diagnosed multiple myeloma.
Lenvatinib was shown to be noninferior to standard therapy with sorafenib in the frontline treatment of patients with unresectable hepatocellular carcinoma.
In an update of the phase II CheckMate-142 trial, the promising antitumor activity of nivolumab in patients with microsatellite instability-high metastatic colorectal cancer was sustained.
Pathologic complete response (pCR) rates were improved by switching neoadjuvant chemotherapy regimens based on PET imaging after induction chemotherapy in patients with esophageal and gastroesophageal junction (GEJ) cancers, according to findings from the phase II CALGB 80803 study.
A supplemental new drug application for the PD-L1 inhibitor atezolizumab has been granted priority review by the FDA in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma as a frontline therapy or following progression occurring ≥12 months after neoadjuvant or adjuvant chemotherapy.
The clinical hold on trials exploring pacritinib has been lifted by the FDA, according to CTI BioPharma, the developer of the JAK2/FLT3 inhibitor.
A supplemental new drug application (sNDA) for the use of regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC) has been granted priority review by the FDA.
The FDA has granted a priority review to a biologics license application for durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed on standard platinum‑based chemotherapy.
The addition of enzalutamide to abiraterone acetate and prednisone failed to improve progression-free survival versus abiraterone and prednisone alone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer who progressed on enzalutamide.
Several phase I trials of vadastuximab talirine in acute myeloid leukemia have been placed on hold by the FDA, according to Seattle Genetics, the manufacturer of the antibody-drug conjugate.
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer.
The FDA has granted a priority review to a supplemental new drug application supporting the conversation of the accelerated approval of palbociclib to a full approval for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.
The phase II HERMIONE trial was halted after the antibody-drug conjugate MM-302 combined with trastuzumab (Herceptin) failed to improve progression-free survival (PFS) versus chemotherapy plus trastuzumab in patents with HER2-positive metastatic breast cancer who had previously received trastuzumab, pertuzumab (Perjeta), and ado-trastuzumab emtansine (T-DM1, Kadcyla).
A new drug application (NDA) for niraparib has been granted priority review by the FDA for use as a maintenance therapy in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy, according to Tesaro, the manufacturer of the PARP 1/2 inhibitor.
The FDA has approved rucaparib (Rubraca) as a treatment for patients with <em>BRCA</em>-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy.
A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial presented at the 2016 San Antonio Breast Cancer Symposium.
The addition of the veliparib to carboplatin/paclitaxel demonstrated promising objective response rates and trends toward improvements in progression-free survival and overall survival in patients with advanced <em>BRCA</em>-positive breast cancer.
Beginning with bortezomib (Velcade) in 2004, there have been 10 agents approved over the last 12 years for the treatment of patients with multiple myeloma.
Combination induction therapy with ibrutinib (Imbruvica) and obinutuzumab (Gazyva) after bendamustine debulking induced a 100% response rate in patients with chronic lymphocytic leukemia (CLL), according to findings from the phase II CLL2-BIG trial.
The combination of lirilumab and azacytidine was well tolerated and showed early signals of activity in heavily pretreated patients with acute myeloid leukemia (AML), according to phase Ib/II findings presented at the 2016 ASH Annual Meeting.
Combining obinutuzumab (Gazyva) with chemotherapy in the first-line setting reduced the risk of disease progression or death by 34% versus rituximab (Rituxan) plus chemotherapy in patients with follicular lymphoma, according to findings from the phase III GALLIUM study.
Brentuximab vedotin (Adcetris) induced responses lasting at least 4 months in 56% of patients with cutaneous T-cell lymphoma versus 13% in patients receiving physician’s choice of standard therapies, according to findings from the phase III ALCANZA trial.
Anti-CD22 chimeric antigen receptor (CAR) T-cell therapy induced an 80% complete remission rate among children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia.
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) for use as a treatment for patients with refractory classical Hodgkin lymphoma.