FDA clears new indication for Adcetris
The Food and Drug Administration today expanded the use of Seattle Genetics’ Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma, or PTCL.
This is the first FDA approval for treatment of newly diagnosed PTCL. The FDA granted this application Priority Review and Breakthrough Therapy designation.
PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells. The T-cells often spread quickly throughout the body and are hard to treat.
Adcetris is a monoclonal antibody that binds to a protein called CD30 found on some cancer cells.
Adcetris is now approved to treat previously untreated systemic anaplastic large cell lymphoma, or ALCL, and other CD30-expressing PTCLs in combination with chemotherapy.
Adcetris was previously approved by the FDA to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma, or cHL; cHL after relapse; cHL after stem cell transplant when a patient is at a high risk of relapse or progression; systemic ALCL after failure of other treatment; and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.
PQA partnership will create rubric for patient-centered quality measurement
The Pharmacy Quality Alliance is partnering with the National Quality Forum and the National Health Council to engage patients and measure developers, and other stakeholders to create the Patient-Centered Engagement Rubric for Quality Measurement.
“Quality measures may be evidence based and valid, but many lack substantive patient participation throughout the measure lifecycle,” PQA director of research and quality strategies Matthew Pickering said. “To be useful, quality measure development must meaningfully incorporate patient input. Creating a patient-engagement rubric specific to quality measurement is an important step in the continuing shift to a healthcare system that is genuinely patient centered.”
PQA is the nation’s leading developer of consensus-based measures for medication safety, adherence and appropriate use, and has been at the forefront of including patients and caregivers in quality measure development.
The NHC provides a united voice for people with chronic diseases and disabilities and their caregivers, and has extensive experience engaging patients to create frameworks and policies to guide health care.
NQF promotes healthcare quality through measurement and improvement, and brings a wealth of patient engagement and policy experience to the process.
“As pioneers in the science of patient centricity and engagement, we are pleased to lend our expertise in rubric development to this partnership,” NHC strategic initiatives senior vice president Eleanor Perfetto said. “We are impressed with PQA’s commitment to integrating the patient voice across its quality measurement work.”
PQA said the initiative is supported by an independent educational grant from Merck.
Former senator joins Blink Health’s board
Blink Health, an app that offers low-cost prescription drug prices, announced that former U.S. senator and New Hampshire attorney general Kelly Ayotte is joining its board of directors.
Ayotte, who has been a senior advisor to Blink since 2017, will take an even more active role supporting the company’s mission of bringing transparency and affordability to the prescription drug industry.
Blink said Ayotte will be a strong advocate for Blink’s mission of increasing accessibility and reducing prescription drug costs for American families. “She will work with the company’s other experienced board members — including executive chairman Bill Doyle, co-founders Geoffrey and Matthew Chaiken, and Tom Tryforos — to support Blink’s continued growth and help expand the company’s efforts to provide the lowest prices on prescription medications,” the company said.
“Kelly understands that Blink threatens industry incumbents who have tried to protect their profits by keeping drug prices high,” Blink Health CEO Geoffrey Chaiken said. “We’re honored to have her join us and confident we will benefit from her expertise and insights.”
“I’ve always been a fierce advocate for improving the U.S. healthcare system and lowering patient costs, so I was drawn to Blink as a new private market solution to the drug price crisis,” Ayotte said. “Blink brings transparency and a patient-centric approach to the prescription supply chain, providing policymakers with an effective model for needed change.”