Expanded Access: Programs & Possibilities
Current Expanded Access Programs
There is no central listing of expanded access or compassionate use programs. If you find a program that’s not listed here, please let us know.
In general, the best way to access a treatment prior to FDA approval is through a clinical trial. All treatments listed here are also being evaluated in clinical trials.
| Drug Name (generic) | Indication | Manufacturer |
|---|---|---|
| 5-azacytidine | refractory acute myelogenous leukemia | National Cancer Institute 301-496-5725 |
| Tarceva®, erlotinib | Non-Small Cell Lung Cancer | Genentech 888-662-6728 |
| Vincristine Sulfate Liposomes Injection (0.16 mg/L) or VSLI | A variety of lymphomas and leukemias | Inex Inex 604.419.3200 (Vancouver, Canada) ask to speak with the Medical Affairs department |
| Virulizin® | advanced pancreatic cancer | Lorus Therapeutics 416-798-1200 ext. 320 |
Experimental Drugs in Phase 3 Clinical Trials
Remember:
- No cancer drug works for every patient who uses it
- Most cancer drugs have significant side effects
- We don't know if a new treatment will be better than the existing treatment until comparison trials are complete.
There are some new drugs - for example, Gleevec - which offer a dramatic improvement to standard treatments. Unfortunately, most new drugs don't fall into that category.
Experimental drugs in phase 3 clinical trials are generally the drugs closest to FDA review and possible approval. Companies tend to be most open to considering access outside of trials for drugs at this stage of development.
The following experimental drugs are in phase 3 clinical trials. They are a treatment option for patients who can enroll in the clinical trials. If you are interested in access to the treatment outside of the trial, you can contact the company directly.
Remember, you cannot force companies to allow access. However, your call may get them thinking about either expanded access or single patient use. Contact us for help.
| Drug Name | Manufacturer | Disease |
|---|---|---|
| MOTEXAFIN GADOLINIUM, Xcytrin® | Pharmacyclics France Bui 1-877-676-0330 medicalaffairs@pcyc.com |
Brain mets, Non-Small Cell Lung |
| BMS-247550, Epothilone | Bristol-Myers Sqibb | Breast |
| GW572016 | GlaxoSmithKline | Breast |
| RPR109881 | Aventis Aventis Call Center 1-800-227-3532 contactus@1800Rxtrial.com | Breast |
| Cci 779, temsirolimus | Wyeth | Breast, Kidney |
| PTK787 | Novartis Joel Hecht, MD, Principal investigator 1-310-206-4303 | Colorectal |
| SU011248 | Pfizer - Sugen | GIST, Kidney |
| Edotecarin | Pfizer 1-800-716-2949 | Glioblastoma Multiforme |
| IL13-PE38QQR | Neopharm | Glioblastoma Multiforme |
| Intratumoral Transferrin-CRM107, TransMID® | KS Biomedix - Xenova Patrick Rossi 1-856-273-6057 | Glioblastoma Multiforme |
| ABT-510 Thrombospondin-1 mimetic | Abbot Laboratories Ray Knight 1-847-938-1378 raymond.knight@abbott.com | Kidney Lymphoma, Sarcoma |
| BAY 43-9006, Sorafenib | Bayer and Onyx Richard Lee, M.D. 1-203-812-3858 | Kidney |
| WX-G250, Rencarex® | Wilex Arie Belldegrun, MD 1-310-794-6584 | Kidney |
| NOLATREXED DIHYDROCHLORIDE, Thymitaq® | Eximias Pharmaceutical Corporation Gregory Suplick 1-610-560-0637 gsuplick@eximiaspharm.com | Liver |
| T138067 Sodium | Tularik Mohammad Hirmand 1-650-825-7278 | Liver |
| Ranpimase, Onconase® | Alfacell Diane Scudiery 1-973-748-8082 | Malignant Mesothelioma |
| BBR2778, pixantrone | Cell Therapeutics Incorporated (CTI) | Non-Hodgkins Lymphoma |
| Idiotype-KLH Conjugate Vaccine, Favid® | Favrille John Gutheil, MD, Protocol chair 1-858-526-8018 | Non-Hodgkins Lymphoma, follicular b-cell |
| MONOCLONAL ANTIBODY B43.13, Oregovomab, OvaRex® | Altarex - Unither Pharmaceuticals | Ovarian |
| TLK286, TELCYTA® | Telik Incorporated | Ovarian, Non-Small Cell Lung |
| PN401, Triacetyluridine | Wellstat Therapeutics Lenny Smith, MS, Protocol chair 1-240-631-2500 ext. 3238 | Pancreatic |
| APC8015, Provenge® | Dendreon | Prostate |
| SATRAPLATIN | Spectrum Pharmaceuticals and GPC Biotech, AG Faith
E. Nathan, MD  1-609-524-1048 sparc-us@gpc-biotech.com |
Prostate |
New Uses for Old Drugs
Companies may apply to the FDA for approval of their drug in new forms of cancer, based on clinical trial results. This approval means that treatment for the new form of cancer is considered non-experimental and your insurance will cover costs. Drugs with multiple approvals include:
| Drug Names | Original Approval/Date | Additional Approvals/Date |
|---|---|---|
| Alimta®, Pemetrexed | Mesothelioma /February 2004 | Non-Small Cell Lung (NSCLC) /August 2004 |
| Taxotere®, Docetaxel | breast /May 1996 | NSCLC/December 1999 Prostate/May 2004 |
| Eloxatin®, Oxaliplatin | Colorectal, second line/Aug-02 | Colorectal, first line/January 2004 |
| Gleevec®, imatinib mesylate | Chronic myelogenous leukemia (CML), refractory/May 2001 | GIST / February 2002 CML, first line/December 2002 |
| Taxol®, Paclitaxel | breast/December 1992 | Ovarian/April 1998 NSCLC/June 1998 |
What if you want a drug that's not listed?
Our Compassionate Use section has extensive information about compassionate use and ways to approach companies that aren't currently offering their drug on a compassionate use basis. If you learn of an expanded access or compassionate use program that we haven’t identified, please let us know.