Prevymis Approved to Prevent Virus in Patients Receiving Stem Cell Transplants
November 9th 2017Prevyis (letermovir) was granted approval by the Food and Drug Administration (FDA) to prevent cytomegalovirus (CMV) infection in adult CMV-seropositive patients treated with an allogeneic hematopoietic stem cell transplant (HSCT). The result is based on a significant reduction in CMV infection rates in a phase 3 study.
FDA Approves Calquence for Mantle Cell Lymphoma
October 31st 2017Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy. The approval was based on objective response rates (ORR) in a single-arm trial.
Blincyto Granted FDA Approval for Leukemia Subset
July 12th 2017Blincyto (blinatumomab) was granted full approval by the Food and Drug Administration (FDA) to treat both children and adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), regardless of Philadelphia chromosome (Ph) status, according to the developer of the anti-CD19 immunotherapy, Amgen.
FDA Approves Tool for Blood Cancer Detection
June 30th 2017ClearLLab multicolor reagents (T1, T2, B1, B2, M) gained approval from the Food and Drug Administration (FDA) to detect chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). This is the first approval the agency received for immunophenotyping on a flow cytometer.
Drug Pair is Active in Melanoma and Head and Neck Cancer
June 7th 2017Patients with squamous cell carcinoma of the head and neck (SCCHC) and those with melanoma saw some promising activity with the drug combination of epacadostat and Opdivo (nivolumab), according to findings from the phase 1/2 ECHO-204 study presented at the 2017 ASCO Annual Meeting.
Will There Be an Immunotherapy Approval in Gastric Cancer?
June 5th 2017Keytruda (pembrolizumab) showed promising signs of clinical activity for patients with advanced gastric or gastroesophageal junction (GEJ), according to updated findings from KEYNOTE-059 study that were presented at the 2017 American Society for Clinical Oncology (ASCO) Annual Meeting.
Kidney Cancer Trial Recommended to Halt
February 23rd 2017An independent data monitoring committee recommended that the phase 3 ADAPT trial exploring rocapuldencel-T (AGS-003) for the frontline treatment of metastatic renal cell carcinoma (mRCC) be stopped, but Argos Therapeutics explained that they will keep the trial open.