European Regulators Make Decisions on Several Companies’ Drugs
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections.
#1. Pfizer’s Mylotarg (gemtuzumab ozogamicin) was recommended for approval. The drug is a cancer antibody drug conjugate (ADC) used in combination with chemotherapy drugs cytarabine and daunorubicin to treat CD33-positive acute myeloid leukemia (AML) in treatment-naïve patients 15 years or older. The U.S. Food and Drug Administration (FDA) approved Mylotarg in the U.S. for treatment-naïve CD33-positive adults and refractory AML patients two years of age or older recently, and in May 2000 for relapsed adult patients. But the drug was voluntarily taken off the market in 2010 after follow-up trials didn’t verify clinical benefit compared to safety concerns.
Pfizer Inc. continued to manufacture the drug so it would be available for compassionate use in Europe, which also allowed independent researchers the chance to continue studying the drug. The company also conducted the ALFA-0701 clinical trial that used an alternative fractionated dosing regimen with the idea that it would improve the tolerability, which provided the data to refile with the EMA and FDA. The FDA approved it in September.
“There is an urgent need to improve outcomes for leukemia patients in Europe,” said Mace Rothenberg, Pfizer’s chief development officer, in a statement. “If approved, the addition of Mylotarg to standard chemotherapy will provide an important new treatment option for patients with AML who would typically be treated with chemotherapy alone.”
The CHMP also had negative opinion over Pfizer’s request for an extension of therapeutic indication for Pfizer’s Sutent (sunitinib), a GIST, pancreatic neuroendocrine tumor and metastatic renal cell carcinoma drug. The CHMP argued that the data showing it delayed a return of the cancers was not convincing.
#2. BioCryst Pharmaceuticals’ Alpivab (peramivir). Based in Durham, North Carolina, BioCryst Pharmaceuticals, Inc. received the nod from the CHMP for a neuraminidase blocker to treat uncomplicated influenza. It had already been approved by the FDA.
#3. Puma Biotechnology’s Nerlynx (neratinib). The CHMP declined to recommend Nerlynx for approval. It is an oral blocker of HER1, HER2 and HER4 kinases, for adjuvant treatment of HER2-positive early stage breast cancer. The FDA approved the drug for early-stage, HER2-positive breast cancer in July 2017.
“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”
#4. AMMTeK’s Amglidia (glibenclamide). Based in Paris, France, AMMTek’s Amglidia received marketing authorization for treatment of neonatal diabetes in newborns, infants and children.
#5. Gilead Sciences withdrew its application for extended us of Zydelig (idelalisib) for chronic lymphocytic leukemia. Gilead Sciences, Inc. argued that its trial data met the primary endpoint for progression-free survival and improved overall survival, but the EMA requested longer-term data.