Sun Pharma har presentert data om ODOMZO® (legemiddel for behandling av hudkreft) og LEVULAN® KERASTICK® + BLU-U®, (for behandling av precancerøse lesjoner) som støtter sikkerhet og effekt.
ODOMZO®
ODOMZO® (Sonidegib) ble godkjent av FDA i juli 2015. Denne ble kjøpt opp av Sol Farma fra Novartis i desember 2016 for 175 millioner dollar forskuddsbetaling sammen med milepælsbetalinger.
It is a prescription medisin taken orally in the form of tablet to treat locally advanced basal cell carcinoma, that has resurfaced following surgery or radiation or that cannot be treated with surgery or radiation. This is an inhibitor of the Hedgehog signalling pathway. The Hedgehog (Hh) pathway is active during embryogenic development and is necessary for cell differentiation, tissue polarity, and stem cell maintenance. This pathway is silent in adult tissues under normal physiological conditions, however, aberrant Hh signalling activation has been implicated in the development and promotion of certain types of kreft, including basal cell carcinoma (BCC), medulloblastoma, and gastrointestinal kreft. Basal cell carcinoma and squamous cell carcinoma are most common forms of nonmelanoma hudkreft og påvirker mer enn tre millioner amerikanere hvert år.
BOLT klinisk studie for Odomzo, en dobbeltblind, randomisert, kontrollert, 42-måneders studie evaluerte ODOMZO 200 mg daglig hos 230 pasienter med lokalt avansert basalcellekarsinom (laBCC) og metastatisk basalcellekarsinom (mBCC). 2-års samlede overlevelsesrater ble funnet å være 93.2 % (laBCC) og 69.3 % (mBCC). Stoffet ble trygt tolerert.
LEVULAN® KERASTICK® + BLU-U®
This is only photodynamic therapy for forkreft hud lesions approved by the FDA (in July 1999) for use on the upper extremities to treat ‘minimally to moderately’ thick actinic keratoses of the face, scalp or upper extremities. These are forkreft skin growths that, if left untreated, may turn into squamous cell carcinoma. While only about 10 per cent of actinic keratoses become kreft, the majority of squamous cell carcinoma cases start as actinic keratosis.
LEVULAN KERASTICK 20 % topical solution, plus blue light illumination is used to treat the lesions. After LEVULAN KERASTICK topical solution has been applied, the treatment site becomes photosensitive and patients should avoid exposure of the photosensitive treatment sites to sollys or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours.
I de kliniske studiene var det en signifikant større clearance av lesjoner (80.6 %) hos pasienter behandlet med denne behandlingen sammenlignet med placebo (45.5 %). I tillegg var det en signifikant større clearance av større sykdomsområde hos 80 % av pasientene som tok denne behandlingen sammenlignet med 40 % med placebo. Behandlingen ble godt tolerert uten rapporter om klinisk signifikante bivirkninger.
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