Erytech’s Public Policy – Compassionate Use (Expanded Access)

Erytech has no marketing approvals for any of its products throughout the globe.

Erytech is a science-led organization researching and developing new medicines through its  ERYCAPS® platform. We are currently operating in North America and Europe.

This policy sets out the general principles for Erytech providing compassionate use. It is intended as global guidance, although Erytech will act in strict accordance with all local country laws and regulations on providing compassionate use.

Erytech’s lead product, eryaspase, is supported by clinical evidence from late stage clinical development1.

Erytech is currently conducting late stage clinical trials in second-line pancreatic cancer (Trybeca-1) in Europe and the US, and in first-line Triple Negative Breast Cancer (Trybeca-2) in Europe. More details, including participating investigator centres, can be found on CT.gov or by sending an email to:

medaffairs@erytech.com

Erytech recognises that not all cancer patients will be suitable candidates for these studies. Where enrolment into a clinical trial is not an option for them, it may be in the interest of patients to have access to eryaspase. Under these circumstances, and where patients are in a life-threatening situation with no satisfactory alternative treatment options, Erytech may provide a treating healthcare professional (HCP) with an investigational medicine such as eryaspase.

As general guidance, Erytech will consider providing Compassionate Use according to the following:

  • Erytech considers the appropriateness of compassionate use for all our investigational medicines early on in the planning of our research programmes. At an early stage in a medicine’s development there could be only limited understanding. For example:
    • Uncertainty on the best way to provide the medicine to patients, such as the exact dose to use and frequency.
    • Establishing the medicine’s efficacy and safety profile.
  • Erytech provides compassionate use in two ways:
    • Formal programmes
      • Patient populations meeting specific criteria managed under a compassionate use protocol.
    • Named (or individual) patients where appropriate and subject to fulfilment of our criteria.
  • All requests for compassionate use, which must be made by an HCP, will be considered by Erytech and according to the following:
    • Patients are in a life-threatening situation.
    • There are no satisfactory alternative treatments (confirmed by the HCP).
    • There is sufficient evidence to believe the potential benefit to the patient justifies the risk.
  • Compassionate use decisions are made by Erytech’s Chief Medical Officer and are final.

 

Other key considerations include:

  • Any concern that compassionate use of the investigational medicine might somehow compromise any related clinical trial or regulatory pathway.
  • Restricted to countries where Erytech is able to provide its product. Currently, this is North America and Europe.
  • That use in formal progammes will only take place in countries where Erytech intends to seek regulatory approval and to make the medicine available; the same limitation will not necessarily apply for named (or individual) patients.
  • That the proposed compassionate use complies with local laws and regulations.

These criteria ensure Erytech has a consistent approach for our decisions on compassionate use.

To investigate further options for the appropriate access to Erytech’s medicines, any HCP can contact Erytech by sending an email to:

medaffairs@erytech.com

Erytech will acknowledge receipt of a compassionate use request submitted by an HCP within 48 hours.

Patients interested in accessing an Erytech medicine for compassionate use should talk to their doctors.

Erytech is committed to transparency in its interactions with HCPs and health care organizations/institutions consistent with applicable laws and/or codes of practice applicable to the pharmaceutical industry. Erytech will fulfil all regulatory requirements to make public information about our compassionate use activities.

1 Hammel P, Fabienne P, Mineur L, et al. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2019;124:91- 101.

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