Oncopeptides position gällande Early Access Program

Oncopeptides engagerar sig för patienter genom innovativ vetenskap och transformativa läkemedel. Patientsäkerheten är av största vikt, och målet är ytterst att tillhandahålla livräddande behandlingar till patienter som har nytta av dem utan att utsätta dem för otillbörliga risker.

Purpose

Oncopeptides believes that investigational drugs (not yet approved by the relevant health authorities) should be studied in patients as part of clinical trials designed to generate data on safety and efficacy.  This data can be used to support regulatory authority applications, ultimately resulting in new, approved medicines.  Oncopeptides encourage a dialogue between the patients and their physicians to find opportunities to participate in clinical trials wherever possible.   

In some cases, patients with serious diseases are not eligible for ongoing clinical trials, or clinical trials may not be recruiting in their geographical region. In addition, investigational drugs may not be available between the completion of the registrational clinical trials and regulatory approval or commercial availability. When patients have exhausted all available therapies, Oncopeptides may consider providing an investigational drug outside of a clinical trial through an Early Access Program. 

General Information on Early Access Programs

There exist a variety of local regulations and mechanisms to provide investigational products before regulatory approval or commercial access. Different terms exist locally for these pre-approval access provisions including “Compassionate Use Program”, “Expanded Access Program”, “Named Patient Program”, “Special Access Schemes/Programs”. At Oncopeptides, “Early Access Programs” (EAPs) refer to the mechanisms to provide access to, and supply of, an investigational product outside of clinical trials and before regulatory approval and commercial availability when there is evidence that a patient may benefit from treatment. EAPs include Compassionate Use Programs (CUP) and Expanded Access Programs.  CUPs may be specified on a national basis as Cohort programs or Named Patient Programs (NPP)/individual basis.

  • Oncopeptides cohort programs will only take place in countries where Oncopeptides intends to seek regulatory approval.
  • Early access on an individual basis may take place prior to decision to seek regulatory approval.
  • Relevant approval by the local Medical Products Agency or other competent authority will be sought for either route to early access.

General Criteria

Oncopeptides will evaluate the following criteria before setting up a program (where permitted by local regulation) or considering individual patient requests:  

  • The specific type of program being proposed is permitted according to the local country specific regulations and laws.
  • The investigational drug is not commercially available for the requested indication in the country concerned.
  • The patient is not eligible for, or does not have access to, an ongoing clinical study of the investigational drug.
  • The investigational drug is intended to undergo regulatory approval.
  • Early access cannot be granted if there still is insufficient clinical evidence of benefit from the use of an investigational drug, or if the treatment would pose or is anticipated to pose an unacceptable or excessive risk to the patient.
  • The investigational drug will be used as treatment for a serious or life-threatening disease as defined by laws and regulations of the country concerned.
  • The patient in question cannot be treated satisfactorily with other drugs approved and commercially available in the same indication.
  • Requests for an investigational drug under an EAP must originate from appropriately qualified physician licensed in the country where the investigational drug is to be distributed.
  • The treating physician(s) must be appropriately qualified to administer the investigational drug and follow all relevant safety requirements and procedures.
  • The physician attending to the patient(s) for whom access is sought agrees to comply with all applicable local legal and regulatory requirements in relation to the request, and any requirements in terms of eligibility criteria, safety reporting or other data provision as stipulated by Oncopeptides.

Closing of Early Access Program

Oncopeptides may consider closing a program for various reasons related to the investigational drug, including but not limited to:

  • Commercial availability for a particular need or condition
  • A negative regulatory decision, or a company decision to discontinue the clinical    development
  • New information becomes available about the safety that could substantially change its benefit/risk profile
  • Limited supply or other manufacturing issues

Process for Requesting Access

Early Access requests should be submitted by the treating licensed physician and should include sufficient supporting detail to enable Oncopeptides to evaluate the early access request.  Please include contact information including address, phone number and email address. 

Contact Information:  Oncopeptides Global Medical Information

Email:  medinfo@oncopeptides.com

Patients interested in accessing a Oncopeptides investigational medicine for compassionate use should talk to their treating physician.