Update...Dr. Sharman has a post on this monoclonal...
Genentech has announced an Expanded Access Program (EAP) for Obinutuzumab (GA101) (next generation Rituxan)
EAPS are used for compassionate reasons ... it is unclear if this will apply outside the U.S.
The patient has:
A serious, life-threatening illness
Exhausted all available therapies typically used to treat the disease and is no longer responsive to, or able to tolerate, these treatments
No other viable therapy options, including participation in ongoing relevant clinical trials
The request to Genentech for access to the investigational medicine comes from the patient's qualified doctor
Announcement... Press Release.
'The FDA has granted GA101 Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.
Genentech will open an Expanded Access Program (EAP) to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.'