ICER Releases Draft Evidence Report for Sickle Cell, Scoping Document for Hemophilia
January 25th 2020The Institute for Clinical and Economic Review (ICER) published a draft evidence report on crizanlizumab (Adakveo), voxelotor (Oxbryta), and L-glutamine (Endari) for sickle cell disease, as well as a draft scoping document on valoctocogene roxaparvovec, an investigational gene therapy, and emicizumab (Helimbra) for hemophilia.
FDA Grants Priority Review to Olaparib for HRR-Mutant mCRPC
January 21st 2020The FDA has granted a priority review designation to a supplemental new drug application for olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.
CAR T-Cell Therapy and Beyond: UCART 19 and Anti-BCMA Therapy
January 20th 2020A pair of interviews on investigational therapies whose sponsors reported updates at the 61st American Society of Hematology Annual Meeting and Exposition: UCART19 from Servier and a revamped anti-BCMA therapy ide-cel from bluebird bio.
CAR T-Cell Therapy and Beyond: Off-the-Shelf Therapies Among Innovations at ASH 2019
January 20th 2020Coverage from the 61st American Society of Hematology Annual Meeting and Exposition in Orlando, Florida, featured results for allogeneic or "off the shelf" CAR T-cell treatments and bispecific antibodies.
Sintilimab Injection Plus Chemo Improves PFS in Frontline Nonsquamous NSCLC
January 14th 2020The first-line combination of sintilimab injection plus pemetrexed and platinum-based therapy showed a statistically significant improvement in progression-free survival compared with chemotherapy and placebo in patients with advanced or recurrent nonsquamous non–small cell lung cancer who did not harbor EGFR or ALK abnormalities, according to an interim analysis of the phase III ORIENT-11 trial.
Expert Explains Clinical Developments With Cytoreductive Nephrectomy in mRCC
January 9th 2020Ulka Vaishampayan, MD, discusses the historical management of patients with metastatic renal cell carcinoma and how advances with systemic therapy have impacted the sequencing of cytoreductive nephrectomy in the treatment paradigm.
Safety of Frontline Durvalumab Combo Confirmed in Extensive-Stage Small Cell Lung Cancer
January 4th 2020Few immune-mediated adverse events were observed with frontline durvalumab plus platinum-based therapy and etoposide in patients with extensive-stage small cell lung cancer, and no treatment-emergent antidrug antibodies were elicited by the PD-L1 inhibitor, according to an analysis of the phase III CASPIAN trial reported at the 2019 ESMO Immuno-Oncology Congress.
FDA Approval Sought for Selinexor in DLBCL
December 24th 2019An application has been submitted to the FDA for selinexor for the treatment of patients with relapsed/refractory diffuse large B-Cell lymphoma who have received at least 2 prior multiagent therapies and who are ineligible for stem cell transplantation, including CAR T-cell therapy.
Maintenance Rituximab After R-CHOP Shows Continued Benefit in Older Patients With MCL
December 23rd 2019Induction therapy with R-CHOP followed by maintenance rituximab continued to show improvements in survival and responses compared with R-CHOP and interferon-alpha maintenance in older patients with mantle cell lymphoma.
FDA Approval Sought for Liso-Cel in Large B-Cell Lymphoma
December 19th 2019Bristol-Myers Squibb has submitted a biologics license application to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.
Biologics License Application Submitted for Mantle Cell Lymphoma CAR T-Therapy KTE-X19
December 17th 2019The submission to the FDA for the investigational CAR T-cell therapy is based on data from the phase II ZUMA-II trial for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.