Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Poteligeo® (mogamulizumab)
Compound: mogamulizumab
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- monoclonal antibody. Mogamulizumab is a novel, humanized mAb directed against CC chemokine receptor 4 (CCR4). Engineered by Kyowa Hakko Kirin's POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity. Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014, and with chemotherapy-native CCR4-positive ATL in December 2014. Clinical trials with mogamulizumab are ongoing in the US, EU and other countries.
Company: Kyowa Hakko Kirin (Japan)
Disease: cutaneous T-cell lymphoma - mycosis fungoides - Sézary syndrome
Latest news:
- • On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Poteligeo®, intended for the treatment of mycosis fungoides or Sézary syndrome, the most common subsets of cutaneous T-cell lymphoma, a rare form of non-Hodgkin’s lymphoma. Poteligeo® will be available as a 4-mg/ml concentrate for solution for infusion. The benefits with Poteligeo® are its ability to improve progression-free survival in patients. The most common side effects are drug eruption (including skin rash), infections (including upper respiratory tract infection and skin infections), infusion related reaction, headache, fatigue, peripheral oedema, pyrexia and gastrointestinal disorders (such as constipation, diarrhoea, nausea, stomatitis).
The full indication is: “Poteligeo® is indicated for the treatment of adult patients with mycosis fungoides or Sézary syndrome who have received at least one prior systemic therapy”.
It is proposed that Poteligeo be prescribed by physicians
• On August 8, 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®) for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. The approval of mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, was based on a randomized, open-label, multicenter trial (Study 0761-010; NCT01728805) in patients with active mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Patients enrolled had a median of 3 prior therapies. The trial randomized 372 patients (44% with Sézary syndrome ) to either mogamulizumab-kpkc or vorinostat.
- Progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm. The estimated median PFS was 7.6 months (95% CI: 5.6, 10.2) for those treated with mogamulizumab-kpkc compared with 3.1 months (95% CI: 2.8, 4.0) in the vorinostat arm (hazard ratio 0.53; 95% CI: 0.41, 0.69). The confirmed overall response rate was 28% and 5%, respectively (p<0.001).
- The most common adverse reactions (reported in ?20%) were rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often from infection (16% of all patients). The prescribing information includes warnings for dermatologic toxicity, infusion reactions, infections, autoimmune complications, and complications of allogeneic hematopoietic stem cell transplantation, including severe and refractory graft-versus-host disease.
- The recommended mogamulizumab-kpkc dose is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Mogamulizumab-kpkc is administered on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles until disease progression or unacceptable toxicity.
- • On August 25, 2017, Kyowa Hakko Kirin announced that the FDA has granted Breakthrough Therapy Designation status to mogamulizumab which is being developed for the treatment of mycosis fungoides and Sézary syndrome, in adult patients who have received at least one prior systemic therapy. Mycosis Fungoides and Sézary Syndrome are the most common subtypes of cutaneous T-cell lymphoma .
- Breakthrough Therapy Designation was granted based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study. This global study is the largest randomized trial in CTCL. Kyowa Hakko Kirin is working with investigators on the future presentation and publication of clinical trial results.
- Kyowa Hakko Kirin has also initiated discussions with other regulatory authorities concerning plans for marketing authorization applications for mogamulizumab in CTCL in other countries.
- • On 6-8 September, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for mogamulizumab for treatment of cutaneous T-cell lymphoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2018-08-08
UE authorization:
Favourable opinion UE: 2018-09-20
Favourable opinion USA:
Orphan status USA: 2011-02-11
Orphan status UE: 2016-10-14
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
