Jason M. Broderick

The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancer, according to MacroGenics, Inc., the manufacturer of the Fc-engineered monoclonal antibody.

The FDA has accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.

The FDA has approved the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) as a frontline treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

The FDA has given a fast track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

Pembrolizumab combined with trastuzumab and chemotherapy demonstrated clinical activity in patients with HER2-positive metastatic esophagogastric cancer.

Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

The FDA has approved olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

The FDA has approved ripretinib (Qinlock) for the fourth-line treatment of patients with advanced gastrointestinal stromal tumor (GIST).

The FDA has approved the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

The vaccine BVAC-C demonstrated durable antitumor activity in patients with HPV 16– or HPV 18–positive recurrent cervical cancer, according to findings presented at the 2020 AACR Virtual Annual Meeting I.

The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.

The FDA has granted an accelerated approval to an updated dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg across all indications in adult patients.

The FDA has granted a breakthrough therapy designation to mobocertinib for the treatment of patients with EGFR exon 20–mutant non–small cell lung cancer.

Olaparib significantly improved overall survival versus abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer and BRCA1/2 or ATM mutations.

The FDA has granted an accelerated approval to sacituzumab govitecan-hziy for the treatment of adult patients with pretreated metastatic triple-negative breast cancer.

A New Drug Application (NDA) has been submitted to the FDA for single-agent relugolix for use as a treatment for men with advanced prostate cancer, according to Myovant Sciences, the developer of the oral GnRH receptor antagonist.

The FDA has approved FoundationOne CDx as the registrational companion diagnostic for pemigatinib (Pemazyre), which the agency recently approved for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

The FDA has approved tucatinib (Tukysa) for use in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 1 prior therapy.

Findings from the phase II FIGHT-202 study of pemigatinib in patients with previously treated, locally advanced or metastatic FGFR2-positive cholangiocarcinoma have been published in the Lancet Oncology as the FDA considers a new-drug application (NDA) for the treatment in this setting.

Acalabrutinib (Calquence), a BTK inhibitor approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), is being explored in the CALAVI trial as a treatment for cytokine storm in patients with COVID-19.

Although efforts to “flatten the curve” are showing some signs of hope, the COVID-19 crisis continues to present major challenges to the oncology community.

Leronlimab is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases, and immune signaling.

The FDA has approved the initiation of a double-blind, randomized phase III clinical trial of the oncology supportive care drug tocilizumab (Actemra) for use in combination with standard of care for the treatment of hospitalized adult patients with severe COVID-19 pneumonia, according to Genentech (Roche), the manufacturer of the interleukin-6 receptor antagonist.

The FDA has approved a 420-mg multidose vial of trastuzumab-dttb (SB3; Ontruzant), according to Samsung Bioepis Co., Ltd., the manufacturer of the trastuzumab (Herceptin) biosimilar.

The FDA has granted 2 Orphan Drug Designations to ALPN-101 for the prevention and treatment of acute graft-versus-host-disease (GVHD), according to Alpine Immune Sciences, Inc., the company developing the first-in-class selective dual T cell costimulation inhibitor.

The FDA has granted a Fast Track designation to the combination of the PD-1 inhibitor balstilimab and the CTLA-inhibitor zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer.

The FDA has approved the CINtec® PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas® 4800 HPV Test, according to Roche (Genentech), the manufacturer of the test.

The FDA has granted an orphan drug designation to umbralisib for the treatment of patients with follicular lymphoma, according to TG Therapeutics, Inc, the developer of the dual inhibitor of PI3K-delta and CK1-epsilon.

The antidepressant phenelzine showed antitumor activity in patients with biochemical recurrent castrate-sensitive prostate cancer, according to a pilot study conducted by researchers at the University of Southern California (USC).

The FDA has accepted a Biologics License Application (BLA) for a fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.