FDA approves new Sprycel indication
Bristol-Myers Squibb has received the Food and Drug Administration’s clearance for an expanded indication for Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive, or Ph+ acute lymphoblastic leukemia, or ALL in combination with chemotherapy.
Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population, according to the company.
In addition to this pediatric approval, Sprycel is approved for use in children one year of age and older with Ph+ chronic myeloid leukemia, or CML in chronic phase, or CP.
“We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to pediatric oncology. Building on our previous indication for children with Ph+ chronic myeloid leukemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL,” Bristol-Myers Squibb’s development lead of hematology, Jeffrey Jackson said.
Learning the management side of business
When Susan Novotny-Cannata graduated from the University of Buffalo School of Pharmacy with a bachelor of science degree in 1991, she took a year off and then went for her master of business administration degree. Because she was a part-time student, it took her four years to obtain her MBA.
Although Novotny-Cannata didn’t get her dual degree concurrently, she epitomized why attaining a PharmD and an MBA is a win-win situation for students and their employers.
Novotny-Cannata is the pharmacy operations manager at Wegmans Pharmacy in Buffalo, N.Y., and Erie, Pa., divisions. She is responsible for managing 13 stores and 75 pharmacists. Seven of her colleagues hold the same position within the company.
“I was always interested in the management part of the business,” she said. “In pharmacy school, it was 100% focused on pharmacy and the clinical aspects of the health sciences. I always knew I loved pharmacy and being a pharmacist. I knew I wanted to know more about not only the pharmacy business and healthcare business, but business management in general. Getting an MBA gave me the business acumen and skills for leadership and advancement. It was the best of both worlds that collided.”
Although Wegmans — where she has worked for 27 years — didn’t require that she have an MBA, she said, “It certainly gave me skills in leadership and management to advance to that position more easily than others.” After a year as a staff pharmacist, she was promoted into pharmacy management.
“I always had a desire to manage and lead people. Taking the dual degree gave me two different views, the health sciences discipline of being a pharmacist and the business knowledge on how to manage a pharmacy,” she said.
Lupin’s generic Onfi gets FDA approval
Lupin has received the Food and Drug Administration’s blessing for Clobazam oral suspension, 2.5 mg/mL.
The product is a generic version of Lundbeck’s Onfi oral suspension, 2.5 mg/mL.
It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age or older.
Clobazam oral suspension, 2.5 mg/mL had a market value of approximately $260.2 million, according to IQVIA September 2018 data.