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FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

FDA

The US regulator has given a green light to Kyowa Kirin’s Poteligeo, an antibody for two rare lymphomas affecting the skin, several years after it made its debut in Japan.

Poteligeo (mogamulizumab-kpkc) has been approved by the FDA to treat adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy, and is the first drug to be registered for the latter indication.

Both MF and SS are a rare form of non-Hodgkin’s lymphoma (NHL) collectively known as cutaneous T-cell lymphomas (CTCL), and are notoriously hard to treat. MF accounts for around half of all cases and – while it often grows slowly and can eb controlled with current drugs for many years – can spread to other parts of the body. SS meanwhile affects the skin and lymph nodes, and some consider that it may be an advanced form of MF.

One of the main problems with this form of cancer is delayed diagnosis because its symptoms, which include red, scaly skin and itchiness, can be mistaken for other skin complaints.

Current treatment options include steroids, chemotherapy, radiotherapy and ultraviolet light treatment, but there is a need for additional treatment options for patients who don’t respond, according to the FDA. Topical treatment is used in milder cases, followed by systemic, and Poteligeo now provides an additional option.

The drug targets CCR4, a chemokine receptor that binds to ligands (TARC and MDC) involved in the control of T cell migration. It is thought to be an important pathway by which tumours recruit regulatory T cells to suppress local immune responses and – if blocked – can re-enable immune activity and tumour-killing.

Kyowa Kirin tested that hypothesis in the phase III MAVORIC study, which included 372 MF and SS patients who were treated with either a weekly injection of Poteligeo or chemotherapy with Merck/MSD’s HDAC inhibitor Zolinza (vorinostat) given as a daily oral dose.

Progression-free survival was 7.6 months with Kyowa Kirin’s antibody and 3.1 months with Zolinza, with the improvement seen across both MF and SS patients and different stages of cancer.

The FDA granted priority review and breakthrough status for Poteligeo last year, and an application has also been submitted to the EMA to support marketing in Europe. The company says it plans to launch the product in the US in the fourth quarter.

Kyowa Kirin has been selling Poteligeo in Japan since 2012, and the company says its approval in the US is a key milestone on the path to becoming a  global specialty pharmaceutical company. Three years ago it joined forces with Bristol-Myers Squib b to test it alongside BMS’ PD-1 inhibitor Opdivo (nivolumab) in solid tumours, and has also looked into pairing the drug with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) and experimental CTLA4 candidate tremelimumab.

Sales of Poteligeo in Japan were 1.9bn yen ($17m) in fiscal 2017, and are predicted to be at around the same level in the current year. Kyowa Kirin is also testing the drug in a phase III trial in Japan for HTLV-1 associated myelopathy (HAM), a progressive spinal cord disease caused by a virus which results in painful stiffness and weakness of the legs.

Meanwhile, Amgen acquired rights to mogamulizumab in 2008 for non-cancer indications for $100m upfront and $420m in milestone payments, hoping to develop it for asthma, but abandoned the project in 2014.

Article by
Phil Taylor

9th August 2018

From: Regulatory

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