MSN's Generic Carfilzomib Receives Approval in the U.S.
Eugia's Generic Carfilzomib Receives Approval in the U.S.
Sanofi has reported data from the Phase III IKEMA clinical trial where its Sarclisa (isatuximab) plus carfilzomib and dexamethasone (Kd) combination therapy showed exceptional median progression free survival (mPFS) in relapsed multiple myeloma patients.
SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with Kyprolis® (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. This approval follows Janssen's regulatory submission to the FDA in February 2021.
Sanofi Canada is announced that Health Canada has approved Sarclisa in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis®). This product was developed in collaboration with Natco Pharma Limited.
BERLIN, Conn., June 16, 2021 /PRNewswire/ --Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis®). This product was developed in collaboration with Natco Pharma Limited. Breckenridge received final approval for the 10mg and 60mg strengths and tentative approval for the 30mg strength. Onyx Therapeutics, Inc., Breckenridge and Natco have reached a Settlement Agreement and the District Court case against Breckenridge and Natco has been dismissed. By virtue of the settlement, Breckenridge has been granted a license permitting the launch of its generic carfilzomib product on a date that is held as confidential in 2027 or sooner depending on certain occurrences. The parties cannot make further comment as to the terms of the Settlement Agreement. According to industry sales data, Kyprolis generated annual sales of $711 million during the twelve months ending April 2021.
Natco Pharma announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS), from the U. S.
The European Commission has approved Sanofi’s Sarclisa in combination with standard of care regimen carfilzomib and dexamethasone (Kd) for the treatment of relapsed multiple myeloma.
The National Institute for Health and Care Excellence (NICE) has recommended a triple combination therapy comprised of Amgen’s Kyprolis, lenalidomide and dexamethasone for the treatment of previously-treated multiple myeloma patients.