FDA OKs third Lenvima indication
Eisai and Merck have received the Food and Drug Administration’s blessing for its kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma, or HCC.
Lenvima was first approved in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. In May 2016, the drug was approved in combination with everolimus for patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.
This new approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.
“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” Memorial Sloan Kettering Cancer Center medical oncologist Ghassan Abou-Alfa said in a press statement. “Reflect is the first-ever positive Phase 3 trial against an active comparator in unresectable HCC. The efficacy and safety data from Reflect are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it.”
“Eisai strives to be a leading global R&D-based pharmaceutical company, driven by our human healthcare mission to improve the lives of patients and their loved ones,” said Shaji Procida, Eisai president, chief operating officer and commercial head of the oncology business group of the Americas, in a press statement. “That purpose is what has propelled us toward this win for patients with unresectable hepatocellular carcinoma. Our goal is to bring monumental solutions to patients and healthcare providers, changing expectations for the oncology landscape, and we look forward to continuing this work in our ongoing collaboration with Merck.”
“We are pleased by the FDA approval of Lenvima as it marks an important advancement in the treatment of unresectable hepatocellular carcinoma,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, in a statement. “With our shared mission to find solutions for difficult-to-treat cancers, we look forward to working with Eisai to help bring this needed option to patients and physicians.”
Novadoz Pharmaceuticals to launch first 3 U.S. generics
Novadoz is set to roll out its first three generics in the United States. The Piscataway, N.J.-based U.S. sales and marketing affiliate of Hyderabad, India-based MSN Group received approval for the products in the fall of 2017.
The products it’s set to launch are rosuvastatin calcium, a generic of cholesterol-lowering drug Crestor; 400-mg moxifloxacin hydrochloride tablets, a generic of anti-infective Avelox; and breast cancer treatment capecitabine, a generic of Xeloda, in 150- and 500-mg tablets.
“This is a major milestone for MSN Group as we are moving up the value chain,” MSN chairman M.S.N. Reddy said. “Based on our vertical integration model, we are hopeful to bring more affordable medicines to the U.S. market in the near future.”
Novadoz president of North America generics, Seshu Akula, said, “The recent approvals for rosuvastatin, capecitabine and moxifloxacin mark a significant event for the commercialization of the MSN Group’s entry into the U.S market with finished dosage forms. Novadoz will benefit from the company’s vertical integration of API and intermediates, expertise in product development and technology, along with the company’s ability to manufacture high barrier of entry products,”
Hy-Vee pharmacies are set to give flu vaccines in store and corporate locations
The flu vaccine for the upcoming flu season is available at more than 250 Hy-Vee Pharmacy locations throughout its eight-state region without an appointment or prescription as allowed per state law during regular pharmacy hours, the company announced Friday.
In addition, Hy-Vee Healthy You mobiles can be reserved for flu vaccine clinics at a company. Clinics are typically held September through November.
Hy-Vee pharmacists conduct a screening process to ensure that they are administering the vaccine type most beneficial for each individual.
People at high risk of serious flu complications include young children, pregnant women, those with chronic health conditions, and individuals ages 65 years old and older.
Medicare and most insurance plans cover the flu vaccine and other immunizations at no charge.
Each person who receives a flu vaccine at a Hy-Vee Pharmacy also will receive a 20 cents per gallon Fuel Saver discount, which can be redeemed at any Hy-Vee Gas location.