FDA News

CLR 131, a targeted, molecular radiotherapy, showed a 33% overall response rate in patients with diffuse large B-cell lymphoma.

The FDA has approved the R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL).

The FDA approved ramucirumab (Cyramza) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) with an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib (Nexavar).

Pembrolizumab was granted a priority review to treat patients with advanced small-cell lung cancer whose disease progressed on 2 or more lines of prior therapy.

The FDA has approved the combination of ibrutinib (Imbruvica) and obinutuzumab (Gazyva) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor.

The FDA has issued a letter about a possible risk of increased mortality among patients with a type of arterial disease who have paclitaxel-coated implants.

The FDA has approved the first rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy.

The Food and Drug Administration (FDA) has approved the use of brentuximab vedotin (Adcetris) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

The Food and Drug Administration (FDA) has granted a breakthrough therapy designation to brentuximab vedotin (Adcetris) for use in combination with chemotherapy for the first-line treatment of CD30-expressing peripheral T-cell lymphoma (PTCL).

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib (Lynparza) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

The FDA has granted pembrolizumab (Keytruda) an accelerated approval for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib (Nexavar), according to Merck, the manufacturer of the PD-1 inhibitor.

The Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) to expand its use in women and men aged 27 to 45 years.

The Food and Drug Administration (FDA) approved a supplemental new drug application for the multikinase inhibitor lenvatinib (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma.

The FDA has granted a second breakthrough therapy designation to the combination use of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.

The FDA has granted a breakthrough therapy designation to atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma (HCC).

The FDA announced today that it has approved the first biosimilar for the treatment of multiple types of cancer.

The FDA has approved a new agent for the treatment of severe hepatic veno-occlusive disease, a rare but often fatal complication in patients who receive chemotherapy and hematopoietic stem cell transplantation.

The FDA has granted an accelerated approval for Tagrisso (osimertinib) to treat patients with advanced non–small cell lung cancer (NSCLC) positive the EGFR T790M mutation and whose disease worsened following a prior EGFR TKI.