Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

The Multiple Patient Expanded Access Program is designed to provide treatment access to
olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian,
fallopian tube or primary peritoneal cancer who are in response (complete response or partial
response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two
150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg
tablet is available for dose reduction. Treatment may continue until disease progression,
unacceptable toxicity or withdrawal of patient consent. The program will collect
observational data only.

Inclusion criteria

For inclusion in the program patients must fulfill the following criteria:

- Provision of informed consent prior to any program specific procedures

- Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade
epithelial ovarian, primary peritoneal or fallopian tube cancer

- Patient is in response (complete response or partial response) following
platinum-based chemotherapy.

- Patients must have normal organ and bone marrow function measured within 28 days prior
to administration of program treatment.

- Postmenopausal or evidence of non-childbearing status for women of childbearing
potential.

Exclusion criteria:

Patients should not enter the program if any of the following exclusion criteria are
fulfilled:

- Patients with a known hypersensitivity to olaparib or any of the excipients of the
product.

- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.

- Concomitant use of known strong or moderate CYP3A inducers. The required washout
period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3
weeks for other agents.

- Patient with moderate or severe hepatic impairment.

- Breast feeding women.