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(0) -- Primary study endpoint demonstrates 86 percent response rate for patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil -- Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis Rheumatology [doi.org/10.1002/art.41731]. The Reducing Immunogenicity of Pegloticase (RECIPE) trial demonstrated that 86 percent of patients (19 of 22) receiving co-therapy of KRYSTEXXA with the immunomodu...

Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI ® The U.S. Food and Drug Administration approved Pfizer Inc.’s supplemental New Drug Application for LORBRENA ® expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase -positive non-small cell lung cancer . LORBRENA is now indicated for … Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI ® The U.S. Food and Drug Administra...

Posted on 8403 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal d...

Press release content from Business Wire. The AP news staff was not involved in its creation. LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA December 28, 2020 GMT NEW YORK--(BUSINESS WIRE)--Dec 28, 2020-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCL...