Pfizer's Mylotarg Likely To Get New Orphan, Biologics Exclusivities
Return to market for leukemia drug expected to generate another orphan drug exclusivity from new indication; Mylotarg also appears on track for 12-year biologics exclusivity after being approved as BLA, rather than an NDA as it was for its initial 2000 approval.
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Pfizer's Three-Pronged Oncology Strategy Includes Expanding Ibrance, Xtandi, Developing Blockbuster Combos
Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.
Original new drugs and biologics recently approved by US FDA.
Agency's Oncologic Drugs Advisory Committee had only discussed gemtuzumab as a treatment for adults with acute myeloid leukemia at its July meeting, but labeling includes a pediatric claim based on a 29-patient trial; drug returns to the US market after being withdrawn in 2010 for failure to confirm clinical benefit.