Technology evaluation: gemtuzumab ozogamicin, Celltech Group.
Gemtuzumab ozogamicin (CMA-676) is a cytotoxic drug (calichaemicin) linked to a human monoclonal antibody that targets CD33, and which has been jointly developed and launched by Celltech Group and the Wyeth-Ayerst Research division of American Home Products as a treatment for acute myeloid leukemia (AML). Wyeth-Ayerst submitted an NDA to the US FDA in October 1999 for approval to treat AML patients who have relapsed after initial chemotherapy [346494]. In January 2000, the FDA assigned CMA-676 Priority Review status [351745], and in March 2000, the US FDA's Oncologic Drugs Advisory Committee voted that there was sufficient evidence of improved safety and acceptable efficacy to support accelerated approval for the treatment of AML in patients who have relapsed following initial chemotherapy [360113], [361883]. In May 2000, the FDA gave final approval for CMA-676 for the treatment of patients of 60 years and over in first relapse with CD33+ AML who are not considered candidates for cytotoxic chemotherapy [367212], [367215]. CMA-676 was launched (as Mylotarg) in the US on 1 June 2000 by AHP. An EMAA is in preparation and is expected to be submitted by the end of 2000 [382163]. In September 2000, Merill Lynch predicted sales of 2.9 million Pounds in 2002, rising to 17.9 million Pounds in 2004 [383742], while in January 2000, Lehman Brothers predicted peak sales in excess of US$200 million [360128]. In December 1999, Lehman Brothers predicted peak sales of US$150 million, with Celltech receiving royalties from AHP. Possible first-line therapy could follow depending on further studies, creating a potential market of US$300 million [352078].
Niculescu-Duvaz
I
I
CRC Centre for Cancer Therapeutics, Institute for Cancer Research, Sutton, Surrey, SM2 5NG, UK. ion@icr.ac.uk
D000617:Aminoglycosides; D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001709:Biotechnology; D001853:Bone Marrow / Q000187:drug effects; D000079982:Gemtuzumab; D006801:Humans; D000922:Immunotoxins / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000378:metabolism; D051379:Mice; D012449:Safety
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000922:Immunotoxins; D000079982:Gemtuzumab