Sunpharma telah membentangkan data tentang ODOMZO® (ubat untuk rawatan kanser kulit) dan LEVULAN® KERASTICK® + BLU-U®, (untuk merawat lesi prakanser) yang menyokong keselamatan dan keberkesanan.
ODOMZO®
ODOMZO® (Sonidegib) telah diluluskan oleh FDA pada Julai 2015. Ini telah diperoleh oleh matahari Pharma daripada Novartis pada Dis 2016 untuk bayaran pendahuluan $175 juta bersama dengan pembayaran penting.
It is a prescription perubatan 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 kanser, including basal cell carcinoma (BCC), medulloblastoma, and gastrointestinal kanser. Basal cell carcinoma and squamous cell carcinoma are most common forms of nonmelanoma barah kulit dan menjejaskan lebih daripada tiga juta rakyat Amerika setiap tahun.
Percubaan klinikal BOLT untuk Odomzo, kajian dua buta, rawak, terkawal, 42 bulan menilai ODOMZO 200 mg setiap hari dalam 230 pesakit dengan karsinoma sel basal lanjutan tempatan (laBCC) dan karsinoma sel basal metastatik (mBCC). Kadar survival keseluruhan 2 tahun didapati 93.2% (laBCC) dan 69.3% (mBCC). Dadah itu selamat diterima.
LEVULAN® KERASTICK® + BLU-U®
This is only photodynamic therapy for prakanker kulit 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 prakanker skin growths that, if left untreated, may turn into squamous cell carcinoma. While only about 10 per cent of actinic keratoses become kanser, 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 cahaya matahari or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours.
Dalam ujian klinikal, terdapat pelepasan lesi yang lebih ketara (80.6%) pada pesakit yang dirawat dengan terapi ini berbanding plasebo (45.5%). Di samping itu, terdapat pelepasan yang lebih besar daripada kawasan penyakit yang lebih besar dalam 80% pesakit yang mengambil terapi ini berbanding 40% dengan plasebo. Terapi ini diterima dengan baik tanpa laporan mengenai kesan sampingan yang ketara secara klinikal.
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