FDA Approvals, News & Updates

FDA Approves 2 New Biosimilars for Patients with Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On May 15, 2018, the FDA approved epoetin alfa-epbx (Retacrit; Pfizer) as the first biosimilar to epo­etin alfa (Epogen, Procrit; Amgen) for the treatment of anemia caused by chronic kidney disease, myelosuppressive chemotherapy, or the use of zidovudine in patients with HIV. The new biosimilar is also approved to reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. [ Read More ]

Bevacizumab plus Chemotherapy Approved for Several Types of Ovarian Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On June 13, 2018, the FDA approved bevacizumab (Avastin; Genentech), in combination with carboplatin and paclitaxel, for the treatment of patients with resected, stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, to be followed with beva­cizumab monotherapy. Bevacizumab received orphan drug designation for this indication. [ Read More ]

Keytruda Receives 2 New Indications: Metastatic Cervical Cancer and Relapsed Mediastinal Large B-Cell Lymphoma

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On June 12, 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent or metastatic cervical cancer that progressed during or after chemotherapy and whose tumors express PD-L1, as determined by an FDA-approved test. Concurrently, the FDA approved the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic test for determining the PD-L1 status in this patient population. [ Read More ]

Kymriah Approved for Adults with Relapsed or Refractory Large B-Cell Lymphoma

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On May 1, 2018, the FDA approved a new indication for the immunotherapy tisagenlecleucel (Kym­riah; Novartis), a CD19-directed, autologous T-cell gene therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma for use after ≥2 systemic therapies, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma. [ Read More ]

Tagrisso Now Approved as First-Line Therapy for Patients with Metastatic NSCLC and EGFR Mutations

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates

On April 18, 2018, the FDA approved osimertinib (Tagrisso; AstraZeneca Pharmaceuticals) as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA used its priority review process, and designated osimertinib as a breakthrough therapy for this indication. [ Read More ]

Rubraca Approved as Maintenance Treatment for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates

On April 6, 2018, rucaparib (Rubraca; Clovis Oncology), a poly (ADP-ribose) polymerase (PARP) inhibitor, received a new indication by the FDA for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved complete or partial response with platinum-based chemotherapy. [ Read More ]

Blincyto Approved for Patients with B-Cell ALL and Minimal Residual Disease

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates

On March 29, 2018, the FDA accelerated the approval of a new indication for blinatumomab (Blincyto; Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) whose disease was in remission but was at risk for relapse because of minimal residual disease (MRD). The FDA granted blinatumomab orphan drug status for this indication. [ Read More ]

Adcetris Approved as Initial Treatment for Stage III or IV Classical Hodgkin Lymphoma

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates

On March 20, 2018, the FDA approved a new indication for brentuximab vedotin (Adcetris; Seattle Genetics) as a first-line treatment, in combination with chemotherapy, for adults with untreated stage III or stage IV classical Hodgkin lymphoma. The FDA approved this indication using its priority review process and designated brentuximab vedotin as a breakthrough therapy. [ Read More ]