In the News

Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 21, 2018, the FDA accelerated the approval of venetoclax (Venclexta; AbbVie/Genentech), in combination with azacitidine (Vidaza), decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥75 years or those with comorbidities that preclude intensive induction chemotherapy. [ Read More ]

Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 16, 2018, the FDA approved brentuximab vedotin (Adcetris; Seattle Genetics), in combination with chemotherapy, for patients with untreated systemic ­anaplastic large-cell lymphoma (sALCL) or with other CD30-­expressing peripheral T-cell lymphomas (PTCLs), including angioim­munoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA-approved drug for newly diagnosed PTCL, including sALCL. Brentuximab vedotin was previously approved by the FDA for classical Hodg­kin lymphoma. [ Read More ]

FDA Approves Expanded Use of HPV Vaccine Gardasil 9

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On October 5, 2018, the FDA approved the expanded use of the human papillomavirus (HPV) vaccine Gardasil 9 (9-valent vaccine, recombinant; Merck) to include men and women between the ages of 27 and 45 years. The FDA initially approved Gardasil 9 in 2006 for younger people (male and female) aged 9 years to 26 years. This HPV vaccine can prevent some types of cancers, including genital and oral cancer, as well as other diseases caused by 9 variants of HPV infection. [ Read More ]

Xospata First Therapy Approved for Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 28, 2018, the FDA approved gilteritinib (Xospata; Astellas Pharma) for adult patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation, as identified by an FDA-­approved test. The FDA approved gilteritinib using its fast track and priority review and granted it an orphan drug designation. [ Read More ]

Vitrakvi Second Drug Approved Based on a Genetic Biomarker, Not a Tumor Type

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 26, 2018, the FDA accelerated the approval of larotrectinib (Vitrakvi; Loxo Oncology/Bayer) for the treatment of patients whose cancers have a specific genetic biomarker. This is the second drug to receive FDA approval based on a biomarker rather than a specific tumor type or site. The first drug to receive this type of approval was pembrolizumab (Keytruda), in 2017. [ Read More ]

Daurismo New Treatment Approved for Older Adults with Acute Myeloid Leukemia

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 21, 2018, the FDA approved glasdegib (Daurismo; Pfizer), an oral Hedgehog inhibitor, in combination with low-dose cytarabine (LDAC), for patients with newly diagnosed acute myeloid leukemia (AML) who are aged ≥75 years or who have comorbidities that preclude use of intensive induction chemotherapy. The FDA approved glasdegib using its priority review and granted it an orphan drug designation. [ Read More ]

Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First

On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia. [ Read More ]

Lorbrena New Treatment Approved for Patients with Metastatic NSCLC and ALK Mutation

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates

On November 2, 2018, the FDA accelerated the approval of lorlatinib (Lorbrena; Pfizer) as second- or third-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and ALK mutation whose disease progressed during crizotinib (Xalkori) treatment and at least 1 more ALK inhibitor or during alectinib (Alecensa) or ceritinib (Zykadia) therapy as the first ALK inhibitor therapy. [ Read More ]

Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First

On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-­negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as identified by an FDA-approved test. [ Read More ]