NEWS |
FDA APPROVE NEW SKIN CANCER DRUG
locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ‘The FDA approval of Odomzo offers a new and
T
non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring,’ said Bruno Strigini, President, Novartis Oncology. ‘Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients.’
Odomzo approval The Odomzo approval was based on the demonstration of a durable objective response rate (ORR) in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). Patients with laBCC treated with Odomzo 200 mg (n=66) were followed for at least 12 months unless discontinued earlier. The ORR was 58% (95% confidence interval: 45, 70), consisting of 5% (n=3) complete responses (CR) and 53% (n=35) partial responses (PR). A pre-specified sensitivity analysis using an alternative definition for CR, defined as at least a PR according to MRI and/or photography and no evidence of tumor on biopsy of residual lesion, yielded a CR rate of 20%. Among the 38 patients with an objective response, 31 patients (82%) have ongoing responses ranging from at least 1.9 to 18.6 months and the median duration of response has not been reached.
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he US Food and Drug Administration (FDA) has approved Odomzo® (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with
SEVERE ECZEMA TREATED WITH ARTHRITIS DRUG
ODOMZO® (SONIDEGIB) INDICATED FOR BASAL CELL CARCINOMA The most serious risks of Odomzo are
embryofetal toxicity and musculoskeletal adverse reactions including rhabdomyolysis. Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, may occur with Odomzo and other drugs which inhibit the hedgehog pathway. The incidence of musculoskeletal adverse reactions in patients with laBCC treated with Odomzo 200 mg was 68%, with 9% reported as grade 3 or 4. Adverse reactions occurring in more than 10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus. The most frequent grade 3 and 4 laboratory abnormalities occurring in at least 5% of patients were serum creatine kinase (CK) elevation and lipase elevation.
The FDA approval of
Odomzo offers a new and non-invasive treatment option for a potentially
devastating disease that is hard to treat and can be disfiguring.
The BOLT Clinical Trial Data from the Phase II, randomized, double-blind multicenter BOLT (Basal cell carcinoma Outcomes in LDE225 Trial) formed the basis of the FDA’s approval. The primary endpoint was ORR of patients treated with Odomzo 200 mg and 800 mg, defined as the proportion of patients with confirmed complete or partial tumor response, or shrinkage, as measured by a central review committee. There was no evidence of better ORR among patients with laBCC randomized to receive Odomzo 800 mg daily. The evaluation of tumor
response was based on a composite assessment of modified Response Evaluation Criteria in Solid Tumors (mRECIST) that integrated tumor measurements obtained by radiographic assessments of target lesions (per RECIST 1.1), digital clinical photography (World Health Organization (WHO) adapted criteria), and histopathology assessments (via punch biopsies).
August/September 2015 |
prime-journal.com
Researchers at Yale School of Medicine have successfully treated patients with moderate to severe eczema using a rheumatoid arthritis drug recently shown to reverse two other disfiguring skin conditions, vitiligo and alopecia areata. The study is evidence of a potential new era in eczema treatment, they report. The research findings are published early online in the Journal of the American Academy of Dermatology. Eczema (atopic dermatitis) is a chronic condition that causes severe itching and leaves the skin red and thickened. It can adversely affect sleep and quality of life. Standard treatments, such as steroid creams and oral medicines, commonly fail to relieve symptoms in patients with moderate to severe eczema. Based on current scientific models of
eczema biology, assistant professor of dermatology Brett King, M.D. hypothesized that a drug approved for rheumatoid arthritis, tofacitinib citrate, would interrupt the immune response that causes eczema. In the new study, King and his colleagues report that treatment with the drug led to dramatic improvement in six patients with moderate to severe eczema who had previously tried conventional therapies without success. During treatment all six patients
reported significant reduction in itch as well as improved sleep. The redness and thickening of the skin diminished, also. ‘These individuals were not only very
happy with the results, they also expressed a tremendous sense of relief at being comfortable in their skin for the first time in many years,’ King said. King and fellow Yale dermatologist
Brittany Craiglow, MD, had previously shown that tofacitinib citrate regrows hair in patients with an autoimmune-related form of hair loss called alopecia areata. They also published findings reporting the successful treatment of a patient with vitiligo, which can leave widespread irregular white patches all over the body. The researchers note that further
research is needed to confirm the treatment’s long-term efficacy and safety for eczema patients.
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