FDA approves ofatumumab/chlorambucil combo treatment for chronic lymphocytic leukemia
LONDON — GlaxoSmithKline and Genmab A/S announced last week that the Food and Drug Administration has approved a supplemental biologic license application for the use of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.
The FDA approval of the first-line indication is based on results from a Phase III study (Complement 1), which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
“CLL is the most common form of leukemia amongst adults in Western countries, many of whom are elderly with multiple health issues,” said Paolo Paoletti, president of Oncology, GSK. “Today’s approval by the FDA for the use of Arzerra in the first-line setting means that appropriate patients with CLL have a new treatment option.”
“We are pleased that Arzerra has been shown to provide clinical benefit and will now be available in the first-line setting. Arzerra, the first approved therapeutic created by Genmab and developed in collaboration with GSK, is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab,” said Jan van de Winkel, CEO Genmab.
MD Science Lab introduces Swiss Navy Sensitive Skin personal lubricant
POMPANO BEACH, Fla. — MD Science Lab on Monday launched a new personal lubricant called Swiss Navy Sensitive Skin. The new, all-natural lubricant caters to men and woman with sensitive skin.
"Our research indicated that there was a great demand for a lubricant that was not only formulated for sensitive skin but clearly stated it on the packaging," said Ralph Albrecht, MD Science Lab founder. "Shopping for lubricants is confusing enough for consumers, without expecting them to research ingredients before shopping. We are just taking the guesswork out of it and offering a product that feels great."
Swiss Navy Sensitive Skin contains carrageenan, a seawater-based gelatin that is silkier than water and feels like the popular lubricant ingredient silicone. It is glycerin-, paraben- and sugar-free, all natural and vegan, and it leaves skin feeling soft. Swiss Navy Sensitive Skin is available in a 4-oz. bottle.
Doritos keeps consumers guessing with new mystery flavors
PLANO, TX — Doritos, a brand from PepsiCo’s Frito-Lay division, introduced something mysterious to snack food aisles across the country.
Starting this week, consumers will see three new mystery flavors of Doritos Jacked tortilla chips. For an added touch of boldness, fans who try all three of the mystery flavors can vote for their favorite at BoldFlavorExperiment.com. The flavor that snags the most votes will be brought back to store shelves this fall. The flavor names will be disclosed later this summer.
"There’s nothing as bold as stepping into the unknown, and crunching into an unknown mystery chip with over-the-top flavor is one way we’re inviting fans to be bold with the Doritos brand," explained Ram Krishnan, VP marketing, Frito-Lay. "Our Bold Flavor Experiment is the latest example of how we’re rewarding our fans for making bold choices — this time by trying our mystery Doritos Jacked flavors and voting for the bold flavor they like best."
The Bold Flavor Experiment builds on Doritos’ "For the Bold" global marketing campaign, which celebrates the brand’s legacy of empowering its fans to boldly live in the moment, the company said. The Doritos Jacked mystery flavors are available in two sizes: a 10-oz. bag for a suggested retail price of $4.29 and a 3.38-oz. bag for a SRP of $1.49.