Compassionate Use, Off-Label Drugs & Single-Subject INDs
If you’ve tried approved therapies and still need further options, our oncologists provide pathways you may not find elsewhere. We offer access to investigational drugs, off-label treatments, and single-patient INDs guided by expertise, care, and transparency.
Get direct access to groundbreaking therapies and compassionate use programs from our expert oncology team, even for difficult-to-treat cancers.
What These Terms Mean
For patients who have exhausted standard treatment options or are not eligible for clinical trials, the fight doesn’t have to end. At Cancer Center of Southern California, we believe in leaving no stone unturned.
We will fight for patients who still want to pursue treatment, even when they have been told there are no remaining options. Here are some terms you should familiarize yourself with if you’re considering exploring advanced treatment options.
Term
Definition
We sometimes use an unconventional approach to administer treatments using medication already approved by the FDA used for a different cancer type, dose, or setting than its original approval.
There is always a strong scientific rationale for such cases. Many drugs are safely used off-label when scientific evidence supports it. This approach is part of our commitment to fighting cancer with everything available to us.
For patients unable to enroll in clinical trials, this allows access to investigational treatments under FDA programs for individual use.
Regulatory pathways (including FDA’s expanded access programs) that let patients access promising investigational therapies when no other suitable alternatives exist.
Why Do We Offer These Options?
Dr. Sant P. Chawla leads a team recognized for pushing the boundaries in cancer care. Over the decades, he has managed complex and rare cases using these advanced approaches.
These pathways give patients hope, allowing access to treatments not yet widely available. We believe in giving every patient a chance when standard options have been maximized.
While we offer access to non-standard treatments, we do so with rigorous oversight, full disclosure, and respect for your values and quality of life.
What to Expect With This Process
- Initial Consultation & Medical Review - We begin by reviewing your full medical history, scans, pathology reports, and prior treatments to assess eligibility.
- Expert Team Discussion - Dr. Chawla and our specialist oncologists evaluate whether off-label or single-subject IND options are safe, potentially beneficial, and aligned with your treatment goals.
- Regulatory & Manufacturer Coordination - If required, we can also prepare necessary paperwork for institutional review boards and regulatory bodies. We also engage with drug manufacturers to secure access.
- Informed Consent & Risk Discussion - You’ll receive clear information about potential benefits, risks, side effects, and what remains unknown with every option presented to you. Your consent is essential to this process.
- Monitoring & Follow-Up - Once access is granted, your care team monitors responses and side effects to ensure adjustments are made as needed. We also ensure your local care providers are included in the loop.
We Facilitate Your Access to Treatment
Our commitment to your care extends beyond medical expertise. We also offer dedicated support to help you navigate your treatment options.
We have a dedicated insurance team to help you navigate coverage and understand your options.
We can assist patients with applying for financial assistance from pharmaceutical companies, which may provide free treatments if insurance coverage is denied.
For many clinical trials, travel and lodging expenses can be compensated by the sponsor.
Who Might Be a Candidate
You may be considered for these advanced options in the following circumstances.
- Patients whose cancer has not responded to all approved standard therapies.
- Those unable to join clinical trials due to eligibility, location, or other constraints.
- Rare or aggressive cancer types with few treatment options.
- Those seeking to explore all possible safe options before proceeding further.
Risks & Considerations
While off-label drugs & single-subject INDs can offer renewed hope to patients who have run out of mainstream options, it is important to be aware of the risks involved.
- Investigational or off-label therapies may carry unknown risks or side effects.
- Not all treatments will be covered by insurance - some costs may be out-of-pocket (although it may be possible to have a sponsor).
- Regulatory and manufacturer approval may take time or may be denied.
While Dr. Chawla and the rest of our team make every effort to turn things around for every patient, please know that outcomes are not guaranteed.
Our Track Record & Experience
When you come to the Cancer Center of Southern California, we want to assure you that you’re placing your trust in capable hands.
- Dr. Chawla has successfully led multiple INDs and compassionate use cases in rare and advanced cancers (including off-label protocols).
- Our team’s research backbone allows us to stay ahead of emerging therapies so that you get access sooner than many other centers.
- Real patient stories (with permission) have shown improved outcomes and better quality of life after pursuing these options
“Quality of life has been excellent these last five years. I forget that I’m even sick. I totally forget. You live one day at a time, and you enjoy it.”
“I was talking to some other people here who thought I was so lucky to have gotten the referral here so quickly when they said they’d been waiting two years or so to find a place like this.”
“You don’t feel like you’re just a patient. You feel like you’re at home.”
Renew Hope. Let’s Talk.
If you’re facing a difficult diagnosis, we want you to know you're not alone. Our team provides the expertise, support, and personalized treatment options that other centers often can't. You deserve a care plan built for your unique situation.
For appointments, please call us at 310-552-9999 or request an appointment online.
Frequently Asked Questions
Clinical trials follow a strict protocol and often have eligibility criteria. Compassionate use/INDs may be used for patients for whom clinical trials aren’t an option.
They may cover it in some cases, but it depends on your plan as well as other factors. Additionally, your insurance provider may require strong supporting medical documentation or evidence. Our dedicated insurance team will be happy to guide you through the process.
Approval times can vary. Some off-label uses can be arranged relatively quickly. However, single-subject INDs may take longer depending on regulatory requirements.
Yes. Our team designs your plan considering all viable options. This may include combining off-label and single-subject IND options with chemotherapy, surgery, radiation, or supportive care.
