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New monotherapy option for treatment of relapsed or refractory peripheral T-cell Lymphoma
DIFOLTA can be administered without hospitalisation, which reduces burden on hospitals and patients.

Mundipharma announced that DIFOLTA has been launched for the treatment of relapsed or refractory Peripheral T-cell Lymphoma (r/r PTCL) in Japan. It can be administered without hospitalisation, which reduces burden on hospitals and patients.

DIFOLTA, which comes in 20mg injection solution form is listed as a preferred second line treatment, regardless of whether a transplant is required, for r/r PTCL and various PTCL subtypes1. Studies show it has a high overall response rate and it is now an option for Japanese patients.

Mundipharma conducted a phase I/II clinical study of DIFOLTA in Japan a PDX-JP1' - which began in 2013. In 2016, Mundipharma filed the approval application for the medicine based on the results both from the Japan study and a global study2, which led to marketing authorization, approval and now the launch.

In the Japan study3, the overall response rate was 45.0%, or 9 of every 20 patients, despite the median number of previous chemotherapy regimens being three. The median duration of response and overall survival rate was not reached in the Japanese study at the time of data cutoff. In the global study, overall survival was 14.5 months - a significant and favourable comparison to only approximately four-five months in a matched controlled population2.

Due to the aggressive nature of r/r PTCL, fast response to treatment is highly desirable. In the Japan and global studies, 100% and 63% of patients responded to DIFOLTA within the first cycle respectively.

R/r PTCL occurs frequently in people over the age of 654 and spend long hours in hospital, often with a continuous IV infusion, may be a significant burden on people in this age bracket. The time required for a single dose ranges from three to five minutes5, which is much shorter than conventional combination chemotherapy, and means it can be administered without hospitalisation. In this context, DIFOLTA can make a real difference to patients' quality of life.

Mundipharma CEO, Raman Singh, said "DIFOLTA is the second new medicine for the treatment of PTCL that we've recently launched in Japan following Mundesine? (forodesine hydrochloride). We are delighted to expand therapeutic options for Japanese patients with relapsed or refractory PTCL, a disease with a standard of care that is yet to be established. This second treatment is an example our commitment to improving quality of life for patients in Japan and around the world."

  1. NCCN Clinical Practice Guidelines in Oncology (NCCN V1, 2017 Guidelines): Non-Hodgkin's Lymphoma V.3.2016. National Comprehensive Cancer Network, Inc. 2016. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf. Accessed October, 2016
  2. PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma) study is a multicenter, single-arm, open-label, international trial conducted for lapsed/refractory PTCL conducted by Allos Therapeutics for Pralatraxate.
  3. In both trials patients of r/r PTCL received vitamin B12 and folic acid. Starting dose was 30mg/m2/week, administered for 6 weeks consecutively and stop administration on the 7th week. This was one cycle.
  4. National Cancer Research Cetner: PTCL 2015 https://ganjoho.jp/public/cancer/PTCL/index.html
  5. DIFOLTA package insert (Dosage)
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