Summary: supportive care during tovorafenib treatment

Labeled supportive measures comprise ultraviolet protection (sunscreen, sunglasses, protective clothing; the EU SmPC specifies SPF 50 or higher), dermatologic consultation and supportive care for skin reactions, liver function monitoring before treatment, at 1 month, and every 3 months, routine growth monitoring, and effective nonhormonal contraception. In FIREFLY-1 (relapsed or refractory pLGG), the protocol recommended a gentle skin care routine with thick unscented moisturizers and SPF 30 or higher sunscreen for all participants, and 102 of 128 participants with rash (80%) received standard rash treatments, primarily topical steroids or antibiotics, oral antihistamines, and emollients. In a pooled growth analysis of 38 participants, 4 (11%) received a gonadotropin-releasing hormone analogue and 2 (5%) received growth hormone concurrently with tovorafenib. No published supportive care guideline specific to first-line tovorafenib use was identified.

Sun protection: US prescribing information

“Advise patients to use precautionary measures against ultraviolet exposure such as use of sunscreen, sunglasses, and/or protective clothing during treatment with OJEMDA.” (opens the source at this quote in a new tab)
“Monitor for new or worsening skin reactions. Consider dermatologic consultation and initiate supportive care as clinically indicated.” (opens the source at this quote in a new tab)

Sun protection: EU product information

“The use of precautionary measures against ultraviolet exposure such as use of sunscreen (SPF ≥ 50), sunglasses, and/or protective clothing during treatment with tovorafenib is recommended.” (opens the source at this quote in a new tab)

Relapsed or refractory pLGG: protocol skin care and rash management in FIREFLY-1

“It was recommended that all trial patients followed a gentle skin care routine comprising short lukewarm showers/baths, the use of unscented, gentle cleansers and the application of unscented thick moisturizers (creams over lotions) immediately after showers. In addition, the prophylactic use of SPF 30+ sunscreen whenever going outside, with this reapplied every 2 h, and the wearing of sun-protective clothing were recommended for all patients.” (opens the source at this quote in a new tab)
“Patients were to be referred to a dermatology department if cutaneous symptoms were impairing function (for example, if the patient could not sleep or sit still) or were psychosocially bothersome and/or when management techniques failed to resolve the condition.” (opens the source at this quote in a new tab)

Relapsed or refractory pLGG: rash treatments used in FIREFLY-1

“80% (102) of pts received standard of care (SOC) treatments for rash, primarily topical steroids/antibiotics, oral antihistamines, and emollients.” (opens the source at this quote in a new tab)

Growth and endocrine monitoring

“Routinely monitor patient growth during treatment with OJEMDA” (opens the source at this quote in a new tab)

“Monitoring for growth and development should be done prior to initiation, routinely during and following discontinuation of treatment with tovorafenib.” (opens the source at this quote in a new tab)

“Normative data for growth in this patient population are lacking, and future studies of targeted therapies in pLGG should include baseline and longitudinal assessments of endocrine function and monitoring of growth velocity during therapy.” (opens the source at this quote in a new tab)

Concomitant endocrine therapies in treated participants

“Four (11%) were receiving a gonadotropin-releasing hormone analogue for precocious puberty and 2 (5%) were receiving growth hormone replacement concurrent with tovorafenib.” (opens the source at this quote in a new tab)

First-line pLGG: safety monitoring in FIREFLY-2

“In addition to standard ophthalmology examination, monitoring for safety will include physical examination, neurologic examination, dermatology examination, cardiac evaluation, bone assessment (for patients with Tanner stage < 4–5), Karnofsky/Lansky performance score, clinical AEs, laboratory variables and vital signs, including height and weight.” (opens the source at this quote in a new tab)

Nonhormonal contraception

“Women of childbearing potential must use effective non-hormonal contraception such as a barrier method during therapy and for 28 days after the last dose of tovorafenib (see section 4.5 and section 4.6).” (opens the source at this quote in a new tab)

Antiemetic prophylaxis and premedication

No evidence found.

Tovorafenib (DAY101)

Co-prescribed/Concomitant therapies