Jason M. Broderick
Articles
FDA Gives Gilteritinib Priority Review Designation for FLT3+ AML
May 29th 2018Based on data from the ongoing phase III ADMIRAL study, a new drug application for gilteritinib has been granted a priority review by the FDA for the treatment of adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia, according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.
Larotrectinib Granted FDA's Priority Review for NTRK+ Cancers
May 29th 2018A new drug application for larotrectinib has been granted a priority review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an <em>NTRK</em> gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.
Ibrutinib/Obinutuzumab Combo Improves PFS in CLL
May 25th 2018According to topline results from the phase III ILLUMINATE trial, the combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil plus obinutuzumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Risk of PSA Progression Reduced by 94% With Apalutamide in Nonmetastatic CRPC
May 22nd 2018According to results from a posthoc analysis of the phase III SPARTAN trial, apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer.
Nelarabine Increases 4-Year DFS Rate to Over 90% in Pediatric/AYA T-Cell Cancers
May 17th 2018In a cohort of pediatric and young adult patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma, adding nelarabine to escalating-dose methotrexate (C-MTX) induced a 4-year disease-free survival rate of 91%, according to findings released ahead of the 2018 ASCO Annual Meeting.
Niraparib Active as Late-Line Treatment of Pretreated Ovarian Cancer, Irrespective of BRCA Status
May 12th 2018According to top-line results from the QUADRA study, niraparib met the primary endpoint of overall response as a fourth-line or later treatment in patients with ovarian cancer, regardless of <em>BRCA</em> status.
Olaparib Tablets Receive European Approval for Ovarian Cancer, Regardless of BRCA Status
May 11th 2018Olaparib tablets have been approved been the European Commission as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.
Atezolizumab/Cobimetinib Combo Does Not Improve OS in CRC, Phase III Results Show
May 11th 2018According to topline findings from the phase III IMblaze370 study, treatment with the combination of the PD-L1 inhibitor atezolizumab and the MEK inhibitor cobimetinib failed to improve overall survival versus regorafenib in patients with locally advanced or metastatic colorectal cancer who were previously treated.
Survival Improved With Quizartinib in FLT3-ITD+ Relapsed/Refractory AML
May 9th 2018According to findings from the phase III QuANTUM-R study, overall survival was improved with quizartinib compared with chemotherapy in patients with <em>FLT3</em>-ITD–positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation.<br />
Frontline Atezolizumab Granted Priority Review by FDA for NSCLC
May 7th 2018Based on findings from the phase III IMpower150 trial, a supplemental biologics license application for atezolizumab has been granted a priority review by the FDA for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.
Frontline Pembrolizumab Combo Submitted for FDA Approval in Squamous NSCLC
May 3rd 2018The FDA has received a supplemental biologics license application seeking approval for pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer.
Selinexor Demonstrates Promising Results in Heavily Pretreated Myeloma
May 2nd 2018In top-line results from part 2 of the phase IIb STORM trial, selinexor induced an overall response rate of 25.4% in patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the oral SINE compound.
Tisagenlecleucel Granted FDA Approval for Large B-Cell Lymphoma
May 2nd 2018Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
Cemiplimab Receives Priority Review from FDA for Patients with CSCC
May 1st 2018A priority review has been granted by the FDA to a biologics license application (BLA) for the PD-1 inhibitor cemiplimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or those with locally advanced CSCC not eligible for surgery.
Adjuvant Dabrafenib/Trametinib Granted FDA Approval for BRAF+ Melanoma
May 1st 2018Based on data from the phase III COMBI-AD study, the combination of dabrafenib and trametinib has been granted FDA approval for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
FDA Gives Frontline Pembrolizumab Combo Priority Review for Full Approval in NSCLC
May 1st 2018Based on data from the phase III KEYNOTE-189 trial, frontline pembrolizumab has been granted a priority review by the FDA for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer, according to Merck, the manufacturer of the PD-1 inhibitor.
Ramucirumab Falls Short of OS Endpoint in Phase III Urothelial Carcinoma Trial
April 24th 2018The combination of ramucirumab (Cyramza) plus docetaxel led to a positive trend for patients with locally advanced or unresectable metastatic urothelial carcinoma who progressed on platinum-based chemotherapy, however, a statistically significant improvement was not found in overall survival (OS), according to Eli Lilly and Company, the manufacturer of the VEGFR2 inhibitor.
Phase III RCC Trial Stopped After Rocapuldencel-T Falls Short
April 20th 2018The phase III ADAPT trial investigating rocapuldencel-T in patients with metastatic renal cell carcinoma has been stopped by Argos Therapeutics after findings of an interim analysis revealed the immunotherapy was unlikely to meet any of the primary endpoints.
Nivolumab Granted Priority Review by FDA for SCLC
April 19th 2018Based on data from the phase I/II CheckMate-032 trial, nivolumab has been granted a priority review by the FDA for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.
Osimertinib Approved by FDA as First-Line Treatment for Patients with EGFR+ NSCLC
April 19th 2018Osimertinib (Tagrisso) has been approved by the FDA as a frontline treatment for patients with non-small cell lung cancer who have tumors harboring EGFR mutations (either exon 19 deletions or exon 21 L858R substitution mutations). This approval is based off results from a recent phase III study.
No Benefit With Addition of Epacadostat in Pancreatic Cancer
April 18th 2018In findings from the phase I/II ECHO-203 study presented at the 2018 AACR Annual Meeting, there were no clinical responses demonstrated by adding the IDO1 inhibitor epacadostat to the PD-L1 inhibitor durvalumab in patients with pancreatic cancer.
Survival Significantly Improved With Frontline Pembrolizumab Combination in NSCLC
April 17th 2018Results from the phase III KEYNOTE-189 trial were presented at the 2018 AACR Annual Meeting, indicating that the combination of pembrolizumab with standard chemotherapy in the frontline setting reduced the risk of death by more than 50% in patients with nonsquamous non-small cell lung cancer without <em>EGFR </em>or <em>ALK</em> mutations.
Adjuvant Pembrolizumab Significantly Reduces Risk of Recurrence in Stage III Melanoma
April 16th 2018According to phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting and published in the <em>New England Journal of Medicine, </em>adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III melanoma.
Frontline Pembrolizumab Improves Survival in NSCLC With Lower Level of PD-L1 Expression
April 12th 2018Overall survival was improved with the PD-1 inhibitor pembrolizumab versus chemotherapy as a frontline treatment for patients with locally advanced or metastatic non–small cell lung cancer and a PD-L1 expression level ≥1%, according to findings from the phase III KEYNOTE-042 trial.<br />
Adjuvant Axitinib Misses Primary Endpoint in Phase III RCC Trial
April 11th 2018According to findings from the phase III ATLAS trial, disease-free survival was not extended with adjuvant axitinib (Inlyta) versus placebo for patients at high risk of recurrent renal cell carcinoma after nephrectomy.
Duvelisib Granted Priority Review by FDA for CLL and Follicular Lymphoma
April 9th 2018A new drug application seeking a full approval for duvelisib 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 has been granted a priority review by the FDA.
Maintenance Rucaparib Approved by FDA for Ovarian Cancer
April 6th 2018Based on findings from the phase III ARIEL3 trial, rucaparib (Rubraca) tablets have been approved by the FDA for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.
Pembrolizumab Combo Fails to Improve PFS in Melanoma
April 6th 2018According to findings from the phase III ECHO-301/KEYNOTE-252 trial, progression-free survival was not improved with the combination of the PD-1 inhibitor pembrolizumab (Keytruda) and the IDO1 inhibitor epacadostat versus single-agent pembrolizumab in patients with unresectable or metastatic melanoma.
