FDA grants Fast Track Designation to Selinexor for the Treatment of Myelofibrosis
“Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study,” said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. “Selinexor’s unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm. We look forward to continued interaction with the FDA as we advance the development of this promising treatment for patients in need.”
Share:
More News
Elevation Oncology today announced that it has entered into a definitive merger agreement with Concentra Biosciences, LLC, whereby Concentra will acquire Elevation Oncology for $0.36 in cash per share of Elevation Oncology common stock, plus one non-tradeable contingent value right, which represents the right to receive: (i) 100% of the
“The AMPLITUDE study reinforces the power of a biomarker-driven approach and the potential of this novel combination regimen to shift the treatment paradigm in prostate cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “By identifying patients most likely to benefit from
“We are gaining significant momentum on CHM CDH17 and look forward to our interactions with the FDA to get our advanced therapy to patients in need”, said Dr Rebecca McQualter CEO of Chimeric.
“Bringing VVD-214, the only clinical-stage covalent inhibitor of WRN in development worldwide, into our portfolio marks an incredibly exciting moment for Vividion,” said Aleksandra Rizo, M.D., Ph.D., Chief Executive Officer of Vividion. “We are eager to progress development of this compound, building on the encouraging clinical data we’ve seen to
