FDA News

The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.

The FDA granted a priority review to a supplemental biologics license application for frontline atezolizumab in patients with advanced non-squamous non-small cell lung cancer.

The FDA granted a priority review for the biologics license application for lisocabtagene maraleucel (liso-cel), to treat adults with relapsed or refractory large B-cell lymphoma.

The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The agency granted full approval to pemetrexed for injection (Pemfexy), a liquid injection and branded alternative to Alimta, for nonsquamous NSCLC.

The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application (NDA) for avapritinib (Ayvakit) as a treatment for adult patients with fourth-line gastrointestinal stromal tumor (GIST). The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020, according to BluePrint Medicines, the developer of avapritinib.

The FDA has granted a priority review for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

The FDA has granted a priority review to the combination treatment of nivolumab and ipilimumab to treat patients with advanced HCC.

The therapy is now approved for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

The FDA has approved the biosimilar pegfilgrastim for treatment to decrease the incidence of infection exhibited from febrile neutropenia.

The FDA has expanded the approval of aprepitant to include in its label the use of a single dose regimen in patients receiving moderately epigenetic chemotherapy.

The FDA has granted accelerated approval to the combination of lenvatinib and pembrolizumab in the treatment of patients with advanced endometrial carcinoma.

The FDA approved entrectinib for pediatric and adult patients with certain subtypes of solid tumors, including non-small cell lung cancer.

The Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan) for the treatment of blood cancers.

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.