FDA Approves Epoetin Alfa Biosimilar for Chemotherapy-Related Anemia
May 16th 2018The FDA has approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chemotherapy, chronic kidney disease, or use of zidovudine in patients with HIV infection.
Maintenance PARP Inhibitors for Ovarian Cancer Make Meaningful Impact on PFS
May 12th 2018With the approval of rucaparib in April 2018, there are now 3 PARP inhibitors approved for use in the maintenance setting for patients with ovarian cancer who are in a complete or partial response to platinum-based chemotherapy, and they are significantly improving progression-free survival.
FDA Approves Daratumumab/VMP for First-Line Treatment of Multiple Myeloma
May 8th 2018The FDA has approved the monoclonal antibody daratumumab (Darzalex), in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
FDA Grants Priority Review to Atezolizumab Combo as First-Line Treatment for NSCLC
May 7th 2018The FDA has granted a priority review to atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), carboplatin, and paclitaxel for the frontline treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
FDA Approves Drug Combo to Treat BRAF V600+ Anaplastic Thyroid Cancer
May 4th 2018The FDA has approved the use of the combination of the BRAF-inhibitor dabrafenib (Tafinlar) and MEK-inhibitor trametinib (Mekinist) for the treatment of patients with unresectable or metastatic BRAFV600E–positive anaplastic thyroid cancer (ATC).
What the Frontline Osimertinib Approval Means for Treatment of EGFR+ NSCLC
May 3rd 2018Helena A. Yu, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, explains the implications of the approval of osimertinib as the frontline standard of care for patients with EGFR-mutant non–small cell lung cancer.
FDA Approves Tisaganlecleucel for Relapsed/Refractory Large B-Cell Lymphoma
May 2nd 2018The FDA has approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
FDA Approves Adjuvant Treatment Combination for Patients With BRAF+ Melanoma
May 1st 2018The FDA has approved the combined use of dabrafenib (Tafinlar) and trametinib (Mekinist) in the adjuvant setting for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
FDA Grants Priority Review to Cemiplimab for Treatment of Metastatic CSCC
May 1st 2018The FDA has granted a priority review to a biologics license application (BLA) for cemiplimab, a PD-1 inhibitor, for use in the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery.
FDA Grants Priority Review for Frontline Pembrolizumab Combo in NSCLC
April 30th 2018The FDA has granted a priority review for frontline use of the PD-1 inhibitor pembrolizumab (Keytruda) in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.