Drugs titan Pfizer Inc (NYSE:PFE) shares nudged higher as it revealed the US FDA had approved its drug MYLOTARG (gemtuzumab ozogamicin) for use in adults with newly diagnosed CD33-positive acute myeloid leukemia.
The treatment was also green-lighted for adults and children, two years and older with relapsed or refractory CD33-positive acute myeloid leukemia .
It is the first therapy with an indication that includes the children's AML and it is also the only therapy that targets CD33, an antigen expressed on cells in up to 90% of patients.
“Today is an important day for patients, their families and the entire AML community, as the approval of MYLOTARG brings forth a long-awaited treatment option that may lead to deeper, more durable remissions for patients with AML,” said Jorge Cortes from the Anderson Cancer Center.
“After many years, we are finally seeing progress in the treatment of AML, which has renewed my hope in improving outcomes for my patients. I am pleased that I can now offer many adult and pediatric patients targeted treatment with MYLOTARG.”
“The FDA approval of MYLOTARG fills a critical unmet need for many adults and children with AML, which can be fatal in a matter of months or even weeks if not treated and has a high relapse rate,” said Liz Barrett, global president, Pfizer Oncology.
“Based on clinical data, real-world experience and support from the AML community, we are grateful MYLOTARG now has the potential to help a broad range of AML patients.”