People living with cancer need new advances. Unleash the possibilities.
Patients with cancer are looking to us to develop solutions and create new paths to cancer breakthroughs.
We focus on the science –
and the people
We focus on both solid tumors and hematological malignancies. We know the need is great, which is why we scrutinize promising molecules from every angle to unlock their full potential with the goal of developing transformative therapies that enable patients with cancer to lead better, longer lives.
Please see important safety information including link to full Prescribing Information for OGSIVEO at the bottom of this page.
Expanded access & compassionate use
What are the treatment options?
Expanded access, which is also sometimes called “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational medical product for treatment outside of a clinical trial setting, when no comparable or satisfactory alternative therapeutic options are available and prior to its commercial availability.
Does SpringWorks have an expanded access / compassionate use program?
In cases when a patient may not qualify for a clinical trial, there may be no trials available, or a patient has exhausted all available treatment options, SpringWorks may be able to provide access to eligible patients through our Expanded Access Program.
Requests for access to a SpringWorks investigational therapy must be made voluntarily by the patient’s treating physician. Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.
I was told that a desmoid tumor is ‘benign,’ but the pain it causes has changed my life. It pushes on my ureters and kidneys and has wrapped itself around some of my muscles. The shooting pains sometimes leave me unable to physically move at times, much less take care of my young children.”Amy, Desmoid Tumor Patient
Patient advocacy organizations are instrumental in helping us deepen our connections with and learn from the community. We are committed to building lasting relationships with organizations that share our vision and goals to change the lives of the people we aim to serve.
* SpringWorks Therapeutics is providing these links as helpful resources for patients. Inclusion on this list above does not represent an endorsement or a recommendation from SpringWorks for any group or organization. The organizations listed are independent of SpringWorks Therapeutics.
Important Safety Information about OGSIVEO
Diarrhea: Diarrhea occurred in 84% of patients treated with OGSIVEO. Grade 3 events occurred in 16% of patients. Monitor patients and manage using antidiarrheal medications. Modify dose as recommended.
Ovarian Toxicity: Female reproductive function and fertility may be impaired in patients treated with OGSIVEO. Impact on fertility may depend on factors like duration of therapy and state of gonadal function at time of treatment. Long-term effects on fertility have not been established. Advise patients on the potential risks for ovarian toxicity before initiating treatment. Monitor patients for changes in menstrual cycle regularity or the development of symptoms of estrogen deficiency, including hot flashes, night sweats, and vaginal dryness.
Hepatotoxicity: ALT or AST elevations occurred in 30% and 33% of patients, respectively. Grade 3 ALT or AST elevations (>5 × ULN) occurred in 6% and 2.9% of patients. Monitor liver function tests regularly and modify dose as recommended.
Non-Melanoma Skin Cancers: New cutaneous squamous cell carcinoma and basal cell carcinoma occurred in 2.9% and 1.4% of patients, respectively. Perform dermatologic evaluations prior to initiation of OGSIVEO and routinely during treatment.
Electrolyte Abnormalities: Decreased phosphate (65%) and potassium (22%) occurred in OGSIVEO-treated patients.Phosphate <2 mg/dL occurred in 20% of patients. Grade 3 decreased potassium occurred in 1.4% of patients. Monitor phosphate and potassium levels regularly and supplement as necessary. Modify dose as recommended.
Embryo-Fetal Toxicity: Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at maternal exposures below human exposure at the recommended dose of 150 mg twice daily.
Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose.
The most common (≥15%) adverse reactions were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection, and dyspnea.
Serious adverse reactions occurring in ≥2% of patients were ovarian toxicity (4%).
The most common laboratory abnormalities (≥15%) were decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.
CYP3A Inhibitors and Inducers: Avoid concomitant use with strong or moderate CYP3A inhibitors (including grapefruit products, Seville oranges, and starfruit) and strong or moderate CYP3A inducers.
Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors and H2 blockers. If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use).
Consult the full Prescribing Information prior to and during treatment for important drug interactions.
To report suspected adverse reactions, contact SpringWorks Therapeutics at 1-888-400-SWTX (1-888-400-7989) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for OGSIVEO for more information.