The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information.
Pfizer said that the additional requested information asked in the Complete Response Letter (CRL) sent by the US regulator is not related to safety or clinical data submitted in the drug’s application.
The company said it is working with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the US.
“Pfizer believes that biosimilars are critically important to the future of cancer care, with the potential to increase patient access to life-changing therapies that will help address the evolving needs of healthcare systems, patients, physicians and payers,” the company said.
Pfizer’s trastuzumab biosimilar, PF-05280014, is an investigational monoclonal antibody, which had succeeded in the Reflections B3271002 breast cancer trial in late 2016 by meeting the primary endpoint of objective response rate.
PF-05280014 was assessed against trastuzumab in combination with paclitaxel, in first line patients with HER2-positive metastatic breast cancer.
Pfizer then said that a separate trial, known as Reflections B3271004, also met its primary endpoint of steady-state Ctrough concentrations in early breast cancer patients, who were treated with the company’s biosimilar and Herceptin.
Apart from the CRL for the trastuzumab biosimilar, Pfizer made two separate announcements with one of them being the FDA breakthrough therapy designation for Trumenba (meningococcal group B vaccine) and an approval in the European Union for Mylotarg (gemtuzumab ozogamicin).
Trumenba secured the FDA designation for providing active immunization in children in the age group of 1-9 years to protect them against invasive disease caused by Neisseria meningitidis group B (MenB)
On the other hand, Pfizer secured the approval for Mylotarg in combination with chemotherapy from the European Commission for the treatment of previously untreated, de novo, cd33-positive acute myeloid leukemia.