Aplidin (plitidepsin) to be re-evaluated by the EMA for Multiple Myeloma

  • The European Commission (EC) has acknowledged that an expert from the Scientific Advisory Group, who was developing a rival product was allowed to participate in the Marketing Authorization procedure for Aplidin (plitidepsin).
  • The EC requests the European Medicines Agency, EMA, to re-evaluate the application for Aplidin in Multiple Myeloma.
  • This exceptional decision supports what PharmaMar has always maintained, namely that there was a conflict of interest among the EMA experts who evaluated the therapy.
  • The Company will demand the reassessment process to be conducted with absolute impartiality, equality and transparency by the EMA.

Share:

More News

“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,

“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look

“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are