Expanded Access Policy | ADC Technology Treatment | ImmunoGen

Expanded Access Policy

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients.  To accomplish this mission, we conduct clinical trials to assess the safety and efficacy of our ADC product candidates.  The data generated from these trials allow us to obtain the necessary marketing approvals from regulatory bodies such as the U.S. Food and Drug Administration and the European Medicines Agency.  For a list of our clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.

In general, patients obtain access to investigational agents prior to regulatory approval by participating in clinical trials.  There may, however be circumstances in which a patient is facing a serious or life-threatening condition, has exhausted available treatment options, and is unable to participate in a clinical trial.  In those cases, regulators may permit companies such as ImmunoGen to provide special access to investigational medicines outside of a clinical trial setting.  These situations are often called expanded access programs, but are also referred to as compassionate use, early access, pre-approval access, or emergency use.

How Expanded Access Works

Consistent with applicable laws and regulations, ImmunoGen may, at its discretion, provide patients with access to our product candidates through expanded access programs when there is sufficient evidence of the investigational agent’s safety and efficacy to support its use in a particular situation.

Criteria

ImmunoGen reviews multiple factors when considering a request for expanded access to an investigational agent, including:

  • The strength of the clinical data;
  • The benefit-risk profile;
  • The potential impact on the clinical development program;
  • The phase of development;
  • Restrictions imposed by national regulations;
  • The probability and timing of regulatory approval of the marketing application; and
  • Other considerations that ImmunoGen determines are relevant under the circumstances.

At this point in time, ImmunoGen does not offer expanded access to any of its product candidates because the lack of clinical data precludes an assessment of the candidate’s benefit and risk.  ImmunoGen continues to monitor the emerging data from the clinical studies of product candidates in its pipeline.  When the clinical data have advanced to the point where ImmunoGen, regulatory authorities, and treating physicians are able to make an assessment of the potential benefit and risk of expanded access use in individual patients outside the context of a clinical trial, ImmunoGen will consider implementing such a program.

Please refer any questions regarding this policy to scientificaffairs@immunogen.com.

For information on available expanded access programs, please visit www.clinicaltrials.gov and search “expanded access programs.”