MSD receives fourth Breakthrough Therapy Designation for Keytruda
pharmafile | April 19, 2016 | News story | Manufacturing and Production, Research and Development | Breakthrough Therapy Designation, FDA, Hodgkin lymphoma, MSD, Merck, breakthrough designation, breakthrough therapy, keytruda
MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma.
This latest designation is the fourth that Keytruda has received from the FDA, who has also granted it breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer, and advanced colorectal cancer.
This designation is intended to streamline the development and review of a candidate that is planned for use to treat a serious or life-threatening condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Dr Roger M. Perlmutter, president at MSD Research Laboratories, says: “Merck (or MSD outside the US and Canada) has launched an ambitious clinical development program examining the efficacy of Keytruda in a broad range of solid and blood cancers, and out studies of relapsed or refractory classical Hodgkin lymphoma are quite promising. The FDA’s Breakthrough Designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use.”
The granting of this designation is based on data from the ongoing Phase Ib and Phase II KEYNOTE trials evaluating the use of Keytruda in patients with Hodgkin lymphoma. The work in this disease area forms part of MSD’s wider development program for this drug, which is being tested in patients with head and neck cancer, non-small cell lung cancer, and multiple myeloma, among others.
Karuna Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its …
Vivos Therapeutics has announced that it has received 510(k) clearance from the US Food and …
FDA grants breakthrough device designation to Inflammatix’s TriVerity Acute Infection and Sepsis Test System
Inflammatix has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device …