Virtual meetings continue, FDA convenes virtual ODAC meeting, several oncology drugs on tap for approval decisions

Here is the medical news to watch for June 15-21, 2020. There is a lot going on in oncology, but several medical conferences in other areas are continuing into this week. Be careful and be safe. Don’t take chances.

Diabetes: The American Diabetes Association (ADA) Scientific virtual meeting is continuing through June 16.

Endocrinology: The virtual meeting of the Endocrine Society, ENDO Online 2020, is continuing through June 22.

Gastroenterology: The FDA is expected to make a decision by June 19 on a metoclopramide nasal spray to treat female diabetic gastroparesis (Evoke Pharma’s Gimoti, EVK-001). This is the company’s second attempt at approval.

Hematology: The European Hematology Association (EHA) virtual meeting is continuing through June 21.

Infectious diseases: The FDA is expected to make a decision by June 19 on an IV antibiotic (Nebriva Therapeutics’ Contepo, fosfomycin) for complicated urinary tract infections.

Oncology

The FDA is expected to make a decision by:

  • June 16 on expanded approval for pembrolizumab (Merck MSD’s Keytruda), a PD-1 inhibitor, for solid tumors with TMB-H ≥10 mutations.
  • June 18 on expanded approval of burosumab (Ultragenyx Pharmaceutical and Kyowa Kirin’s Crysvita), an IgG1 antibody, to treat tumor-induced osteomalacia.
  • June 18 on expanded approval of tazemetostat (Epizyme’s Tazverik), an EZH2 inhibitor, to treat relapsed/refractory follicular lymphoma

ODAC Meeting

The FDA is holding its first advisory committee meeting in months, and it will be a two-day meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). However, it will be virtual (by teleconference and webcast).

On June 17, the panel will consider two drugs:

  • A treatment for Ewing sarcoma (Salarius Pharmaceuticals’ seclidemstat, SP-2577).
  • A treatment for relapsed/refractory multiple myeloma (Bristol-Myers Squibb/Celgene’s marizomib, NPI-0052).

On June 18, the panel will consider two more drugs:

  • A CAR T therapy for relapsed/refractory CD30+ lymphomas (Tessa Therapeutics).
  • A menin inhibitor for relapsed/refractory acute leukemia (Syndax Pharmaceuticals’ SNDX-5613).

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 590

Topic ID: 88,590,730,12,187,188,118,467,935,190,520,192,590,725,532