Daiichi Sankyo has received permission from the Food and Drug Administration for Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer.
This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.
“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. “Having therapies that are specially tailored to each patient's cancer subtype is a priority to ensure access to safe and innovative treatments.”
HER2 receptors, which are proteins made by the HER2 gene, are important in determining a patient's treatment. HER2-negative includes hormone receptor positive and triple negative breast cancers. HER2-low is a new classification of the HER2 subtype. It describes a new subtype of breast cancer that has some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive.
Patients with HER2-low breast cancer are eligible for Enhertu if they have received a prior chemotherapy in the metastatic setting, or their cancer returned during, or within six months of completing, adjuvant chemotherapy.
ThermaMEDx, based in Atlanta, is debuting EverTears instant heat eye compress + moist cleaning pad for dry eye and stye relief.
EverTears features patented ThermaMEDx technology to instantly heat to the temperature needed to help unblock eyelid glands responsible for most dry eye symptoms. This moist heat also activates the natural power of a proprietary cleaning formula made with essential coconut extracts and fatty acids. When you feel the soothing warmth on your eyelids, EverTears is already working to provide sustained relief of dry eye symptoms with regular use, the company said.
EverTears was inspired by world-renowned doctor and research scientist Michel Guillon. “The ThermaMEDx team is passionate about bringing sustainable relief to patients suffering from dry eye symptoms related to Meibomian gland dysfunction,” the company said.
“Based on over 30 years of research, Guillon patented the world's first self-heating eye compress, featuring a pre-moistened cloth cleaning pad to deliver the two therapies most recommended by doctors in one convenient medical device,” the company said. “EverTears is designed to provide relief from dry eye symptoms while also helping your eyes retain more of your natural protective tear film.”
The product helps restore natural tear film and reduces reliance on artificial tears.
Amber Specialty Pharmacy to dispense Pfizer's oncology portfolio
Sally Hansen is debuting not one, but two new additions to its premium nail care collection, Repair + Rescue.
Curated with results-driven ingredients, the beauty brand’s product launches include:
Bi-Phase Revitalizing Serum: Designed to revitalize nails and encourage nail growth, it is formulated with an MSM biotin blend, blueberry extract and glycerin. It is proven to aid in improving the overall condition of nails and moisture in just two days with regular use; and
Fungal Damage Solution: A quick and easy solution that can aid in improving fungal damage in just one week with regular use. It reduces discoloration and comes with a precision tip that allows for an easy application under the nail.
Retailing for $15 each, Sally Hansen’s new Bi-Phase Revitalizing Serum and Fungal Damage Solution can be found at mass market, drug store, food and e-commerce retailers nationwide.
Cardinal Health appoints Michelle Greene as chief information officer
Michelle Greene has been named chief information officer at Cardinal Health.
Greene will report to CEO Mike Kaufmann and join the company's executive committee.
“Michelle is a proven leader with a wealth of experience across multiple industries,” said Kaufmann. “Innovation is core to our business and we believe, under Michelle’s leadership, we will continue to make advancements to best serve our customers and their patients.”
Greene joined Cardinal Health in 2021 as senior vice president of EIT for the company’s pharmaceutical segment. In that role, she developed IT strategy tailored to the segment’s business objectives. Previously, Greene was CIO and vice president of IT at Masco and spent nearly a decade with Johnson Controls, serving in several executive positions, including vice president of IT.
Greene has a master’s degree in information science from Florida State University and an executive certificate of international business from the Wharton School. She has received numerous awards, including the Top 25 Most Influential Black Women of Business, and is an active member of multiple nonprofit boards.
Janssen receives FDA nod for new indication for Stelara
The Food and Drug Adminstration gave the green light for Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) for the treatment of pediatric patients 6 years old and older with active psoriatic arthritis.
This rare disease that resembles adult PsA affects 5% to 8% of children and adolescents with chronic inflammatory arthritis.
Two of the four indications for Stelara now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate to severe plaque psoriasis.
Stelara is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases. Stelara is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.
“We know active pediatric psoriatic arthritis is a challenging inflammatory disease given its rarity and that symptoms, such as swollen joints and skin lesions, can vary significantly in presentation and severity,” said Terence Rooney, vice president of rheumatology and maternal fetal disease area at Janssen Research & Development.
“With this pediatric approval of Stelara, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy,” he said.
“The approval of Stelara for use in children six years of age and older with active psoriatic arthritis, which follows the 2020 approval for moderate to severe plaque psoriasis in this population, is complemented by more than 12 years of clinical trial and real-world evidence across all approved indications demonstrating the safety and efficacy of this biologic therapy” said said Jennifer Davidson, vice president of immunology medical affairs at Janssen Scientific Affairs. “As a global leader in immunology, Janssen is dedicated to reducing the burden of chronic autoimmune diseases, and this additional approval for Stelara builds on our legacy of bringing important treatment options to younger patients.”