Loxo, Bayer get FDA nod for Vitrakvi
The Food and Drug Administration has granted accelerated approval to Loxo Oncology’s Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature, or biomarker.
This is the second time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released earlier this year.
Developed in collaboration with Bayer, Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase, or NTRK, gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
“Today’s approval of Vitrakvi is the culmination of years of hard work and research by many people to bring the first-ever treatment to patients with TRK fusion cancer. TRK fusions are rare, but occur across many different tumor types. In this era of precision medicine, we are delivering on Bayer’s commitment to advance the future of cancer care while providing value for patients and physicians,” said Robert LaCaze, a member of the executive committee of Bayer’s pharmaceuticals division and head of the oncology strategic business unit. “It is very rewarding to provide a therapy specifically for patients with advanced solid tumors harboring an NTRK gene fusion.”
“Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body,” FDA commissioner Scott Gottlieb said. “This new site agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.”
Teva releases limited doses of generic EpiPen
Teva is offering limited doses of the FDA approved generic version of Mylan’s EpiPen (epinephrine injection) auto-injector 0.3 mg.
Teva’s generic version of the EpiPen Jr auto-injector 0.15 mg and an additional supply of Teva’s generic version of the EpiPen auto-injector 0.3 mg are expected in 2019. The wholesale acquisition cost for the product is $300, Teva said.
Epinephrine injection is used to treat life-threatening, allergic emergencies, including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
“We’re pleased to provide access to epinephrine injection for patients who may experience life threatening allergic emergencies, and we’re fully dedicated toward ensuring additional supply in 2019,” Teva executive vice president and head of North America commercial Brendan O’Grady said.
Diplomat Pharmacy to ship certain medications in ClimaCell coolers
Diplomat Pharmacy is switching from expanded polystyrene, or EPS foam, coolers to TemperPack’s ClimaCell coolers for delivery of temperature-sensitive medications.
ClimaCell coolers are fully recyclable at curbside and insulated with renewable materials that can be recycled wherever plastic bags are accepted.
Diplomat’s efforts will help divert more than five tons of plastic from landfills every week by moving away from EPS foam, according to TemperPack. ClimaCell coolers require 94% less energy to manufacture, meaning reduced carbon emissions, according to the company.
“Switching to ClimaCell not only reduces Diplomat’s carbon footprint; it’s also a reflection of our steadfast commitment to patients,” Diplomat chairman and CEO Brian Griffin said. “It’s difficult to dispose of EPS foam responsibly, and our patients have already expressed their excitement about reducing the amount of plastic heading to landfills. This new packaging allows us to be better stewards of t environment while keeping specialty medications at a stable temperature.”
ClimaCell coolers meet International Safe Transit Association standards, meaning they will keep medication at a safe temperature even in extreme weather conditions.
“Our healthcare system relies on petroleum-based plastics, especially EPS foam. Patients don’t think this is sustainable, and neither do we. ClimaCell is the first in a series of high-tech, plant-based technologies that will empower companies like Diplomat to continue improving human health without compromising environmental health. We are honored and excited to support such an innovative company,” TemperPack cofounder James McGoff said.