FDA Approvals, News & Updates

Luspatercept Effective in Patients with Lower-Risk Myelodysplastic Syndromes

Pivotal phase 3 data demonstrated treatment with luspatercept resulted in statistically significant increased red blood cell transfusion independence compared with placebo.

Tazverik Receives FDA Approval as First Treatment Specifically for Metastatic or Locally Advanced Epithelioid Sarcoma

On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection.

FDA Grants Approval to Avapritinib for Patients with GIST

On January 9, 2020, the FDA approved avapritinib (Ayvakit; Blueprint Medicines), a kinase inhibitor, for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including PDGFRA D842V mutations.

Recap of FDA Drug Approvals in 2019

According to the FDA’s “Center for Drug Evaluation and Research (CDER) Annual Report: New Drug Therapy Approvals 2019,” the agency approved 48 novel drugs in 2019. Although this number does not approach the record of 59 approvals in 2018, it far surpasses the mere 22 approvals that occurred in 2016.

FDA Will Require Early Assessment of New Targeted Agents That May Be Used in Pediatric Cancers

On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.

Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma

On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug designation to the agent for the treatment of soft tissue sarcomas.

November 11, 2019 — Oncology News & Updates

  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens

October 28, 2019 – Oncology News & Updates

In This Article Zejula Now Approved for Late-Line Ovarian Cancer Trump Set to Nominate Hahn as FDA Commissioner FDA Aims to Improve Breast Implant Guidance Zejula Now Approved for Late-Line Ovarian Cancer On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment [ Read More ]

Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News

In This Article Critical Shortage of Pediatric Cancer Drug Leads to Serious Concerns Study Finds Racial Disparities in Multiple Myeloma Treatment FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-Positive Metastatic Breast Cancer The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study [ Read More ]

Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to [ Read More ]

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