Pfizer’s hot hand in oncology continued this week with an FDA OK for glasdegib, an oral drug designed to throw a monkey wrench into the biology driving the hedgehog pathway in acute myeloid leukemia.
The drug, Pfizer’s fourth oncology product approval in just two months, will now be sold as Daurismo in combination with chemo for newly diagnosed cases of AML, when patients can’t tolerate the kind of intensive chemo regime needed to rein in the blood cancer.
In what has become standard operating procedure, Pfizer got the approval on Phase II data, with an overall survival rate that averaged 8.3 months compared to 4.3 months for patients receiving only LDAC.
Pfizer CEO Ian Read recently shrugged off the need to rack up new M&A deals because of its late-stage pipeline, which scored an approval for lorlatinib, now headed for the market as Lorbrena, just 2 weeks ago. Its PARP talazoparib was approved in October. Dacomitinib, a kinase inhibitor now headed for frontline duty against non-small cell lung cancer, was OK’d in late September.
“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities,” says Richard Pazdur, the FDA’s oncology czar, who helped create the regulatory shortcut that now exists for new cancer drugs. “Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs. Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy.”
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