Web Exclusives

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On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology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

November 4, 2019 — Oncology News & Updates

  • Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
  • Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda Advanced Head and Neck Cancers
  • Discussing Costs of Genomic Testing with Patients

Applying CAR T-Cell Therapies to Solid Tumors: Overcoming Current Challenges

Reprogramming patients’ immune cells to treat their cancer has become the front line of cancer therapy, with chimeric antigen receptor (CAR) T-cell therapy now approved by the FDA for several blood cancers. But translating this success to solid tumors remains a challenge. At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, Gianpietro Dotti, MD, Cancer Cellular Immunotherapy Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, discussed efforts to extend the application of CAR T-cell therapy to solid tumors.

FDA on In Vitro Diagnostics, Vaping; Cost of Novel Treatments

FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines.

The Evolving Role of Precision Medicine in Clinical Practice

Genetic alterations in molecular pathways are involved in tumor development, survival, and progression. Precision cancer medicine is about using the cancer genome to guide treatment decisions, according to Christine M. Walko, PharmD, BCOP, Personalized Medicine Pharmacologist, Personalized Medicine Clinical Service, and Chair, Clinical Genomic Action Committee, Moffitt Cancer Center, Tampa, FL.

Evolving Immuno-Oncology Strategies in Renal-Cell Carcinoma

The era of immunotherapy has opened new perspectives in renal-cell carcinoma (RCC), which is one of the tumors most highly infiltrated with CD T-cells and PD-1 expression, partially accounting for its sensitivity to immunotherapy.

Personalized Neoadjuvant Immunotherapy Combinations Improve Outcomes in Stage III Melanoma

Moving combination immunotherapy into the neoadjuvant setting for patients with stage III melanoma induces a higher rate of pathologic response than adjuvant therapy, said Christian U. Blank, MD, PhD, Division of Molecular Oncology & Immunology, Netherlands Cancer Institute, ­Amsterdam, at the 2019 ASCO-­SITC Clinical Immuno-Oncology Symposium.

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