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Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. This indication is approved under the FDA's accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy. With this indication, KEYTRUDA becomes the first anti-PD-1 therapy to be approved for the treatment of PMBCL, a type of non-Hodgkin lymphoma. This is the second indication for KEYTRUDA for the treatment of a hematologic malignancy. "Relapsed or refractory PMBCL is often a challenging disease to treat, and many affected patients are young adults," said Philippe Armand, M.D., Ph.D., medical oncologist in the Hematologic Oncology Treatment Center at Dana-Farber Cancer Institute. "In the clinical trial that supported this approval, treatment with KEYTRUDA resulted in meaningful responses, including complete disease remission in some patients. This approval therefore provides another therapeutic option for patients with PMBCL who have progressed on or after prior therapies."

Merck announced that the U.S.FDA has accepted for review a new supplemental Biologics License Application for GARDASIL 9, the company's 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus types covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act, or target action, date of Oct. 6, 2018.

Agilent Technologies (A) announced that the U.S. FDA has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use. Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with KEYTRUDA, an anti-PD1 immunotherapy manufactured by Merck (MRK). PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.