FDA approves Kyowa Kirin’s Poteligeo for 2 types of rare cancer
Kyowa Kirin received clearance from the Food and Drug Administration for Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS, the agency said upon announcing the drug’s approval.
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Richard Pazdur. director of FDA’s Oncology Center of Excellence, and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF accounts for about half of all lymphomas arising from the skin. It causes itchy red rashes and skin lesions and can spread to other parts of the body. SS is a rare form of skin lymphoma that affects the blood and lymph nodes.
Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.
The FDA said approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival, or the amount of time a patient stays alive without the cancer growing was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months), according to the FDA.
The FDA said it granted this application Priority Review and Breakthrough Therapy designation. Poteligeo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
UnitedHealth reportedly in tentative agreement to buy Genoa Healthcare
Health insurer UnitedHealth reportedly has at least a tentative agreement to buy specialty pharmacy operator Genoa Healthcare from private equity firm Advent International, according to an Axios report.
Bloomberg reported yesterday that Walgreens Boots Alliance was among those suitors interested in Genoa.
Genoa, which is estimated to be worth about $2.5 billion has more than 400 full-service pharmacies within community mental health centers. It serves about 650,000 customers and has more than 250 psychiatrists and nurse practitioners who provide telepsychiatry services to mental-health patients, according to the Bloomberg report.
Genoa CEO John Figueroa is expected to move on and Genoa chief commercial officer Mark Peterson will head the business for UnitedHealth, Axios’ report said.
Seqirus begins shipping 2018-2019 influenza vaccines
Seqirus has started to ship its portfolio of more than 50 million doses of influenza vaccines to the United States in preparation for the upcoming 2018-2019 influenza season, the company announced Wednesday.
The company will provide Fluad influenza vaccine, adjuvanted, which it said is the only adjuvanted seasonal influenza vaccine specifically developed for people ages 65 years and older, as well as Flucelvax Quadrivalent influenza vaccine, available for those aged four and older, according to the company.
The Seqirus 2018-2019 influenza vaccine portfolio also includes Afluria Quadrivalent, an egg-based quadrivalent influenza vaccine, and Rapivab (peramivir injection), which the company said was the first-and-only one-dose intravenous antiviral treatment for acute uncomplicated influenza.