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Date: 2018-09-24

Type of information: Granting of a Market Authorisation in the US

Product name: Copiktra™

Compound: duvelisib (IPI-145)

Therapeutic area: Cancer - Oncology

Action mechanism:

  • phosphoinositide 3-kinase (PI3K) inhibitor. Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies.

Company: Verastem (USA - MA)

Disease:

  • relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies
  • relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies

Latest news:

  • • On September 24, 2018, the FDA has approved Copiktra™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. The drug is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.
  • Copiktra™ also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Use of Copiktra™ is associated with a boxed warning for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on Copiktra™. The most common adverse reactions (reported in ? 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. Copiktra™ will be available in the U.S. market immediately.
  • • On April 9, 2018, Verastem announced that the FDA has accepted for filing with Priority Review its New Drug Application (NDA) for duvelisib. , for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.
  • • On February 7, 2018, Verastem announced it has submitted a New Drug Application (NDA) to the FDA seeking full approval for duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). Duvelisib has received Fast Track Designation from the FDA for patients with CLL or peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.
  • The NDA is supported by clinical data from the randomized Phase 3 DUO™ study demonstrating significant efficacy, along with aconsistent and manageable safety profile, of duvelisib monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study met its primary endpoint with oral duvelisib monotherapy achieving a statistically significant improvement in progression-free survival (PFS) compared to ofatumumab in patients with relapsed or refractory CLL/ SLL (median PFS of 13.3 months versus 9.9 months, respectively; HR=0.52; p<0.0001), representing a 48% reduction in the risk of disease progression or death. The NDA is also supported by results from the Phase 2 DYNAMO™ study in patients with indolent non-Hodgkin’s lymphoma that are double-refractory to both rituximab and chemotherapy or radioimmunotherapy, which also achieved its primary endpoint with an objective response rate (ORR) of 46% (p<0.0001). In the subset of patients enrolled in DYNAMO with double-refractory FL (n=83), duvelisib demonstrated an ORR of 41%.

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: 2018-09-24

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes