FDA Approvals, News & Updates

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 ]

Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Ovarian Cancer

In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them. [ Read More ]