Novartis, Pfizer Lead Pipeline NewsBy
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Novartis and Pfizer.
Editor’s Note: This article isupdated on a continuous basis for news announced from Wednesday July 12, 2017 to Tuesday July 18, 2017.
FDA Advisory Committee Recommends for Approval Novartis’ CAR T Therapy
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee has unanimously recommended for approval Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019 (tisagenlecleucel), for treating relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia.
A biologics license application for this indication is under FDA priority review and if approved, CTL019 could become first CAR-T cell therapy commercially available.
CTL019 was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses as well as persistence of CTL019 after it is infused into the patient, which may be associated with long-lasting remissions in patients, according to Novartis.
In 2012, Novartis and Penn entered into a global collaboration to further research, develop, and commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Children’s Hospital of Philadelphia was the first institution to investigate CTL019 in the treatment of pediatric patients and led the single site trial.
Earlier this month in July 2017, Novartis signed an agreement with Oxford BioMedica, a company specializing in gene and cell therapy manufacturing, for the commercial and clinical supply of lentiviral vectors used to generate CAR T products, including CTL019 (tisagenlecleucel). In February 2016, Novartis and Penn unveiled a center for advanced cellular therapeutics on the Penn campus, which was constructed in part through a $20-million investment from Novartis.
Source : Novartis
FDA Advisory Committee OKs Pfizer’s ADC
The US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee has recommended for approval Pfizer’s antibody drug conjugate (ADC), Mylotarg (gemtuzumab ozogamicin), for treating acute myeloid leukemia (AML).
The role of the advisory committee is to provide recommendations to the FDA. The FDA’s decision on whether or not to approve the Mylotarg application is expected by September 2017..
Mylotarg is an investigational ADC comprised of the cytotoxic agent calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90% of AML patients. When Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell,and calicheamicin is released causing cell death, according to Pfizer.
Mylotarg was originally approved by the FDA in 2000 under an accelerated approval program for use as a single agent in first relapse patients with CD33-positive AML who were 60 years or older. In 2010, Pfizer voluntarily withdrew Mylotarg after a confirmatory Phase III trial at that time did not show a clinical benefit, and the fatal induction toxicity rate was significantly higher in the Mylotarg arm of the clinical trial.
Earlier in 2017, Pfizer’s biologics license application for the leukemia drug was accepted for filing and granted priority review by the FDA.
Mylotarg originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
Currently, there are only two ADCs approved on the market, Seattle Genetics’ Adcetris (brentuximab vedotin), indicated for treating classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma, and Roche’s Kadcyla (trastuzumab emtansine), indicated for treating HER2-positive, metastatic breast cancer.