Odomzo
Oncology· 593 cited findings· 1 source document
Company: Sun Industries B V
What the regulatory reviews say
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy. The recommended dose is 200 mg. The application for marketing authorization was submitted on 5 May 2014, and a positive opinion was issued between 22-25 June 2015.
In the primary efficacy analysis set (pEAS) of 150 patients, the Overall Response Rate (ORR) by central review for sonidegib 200 mg in locally advanced BCC (laBCC) was 42.9%, and for metastatic BCC (mBCC) was 15.4%. For sonidegib 800 mg, the ORR in laBCC was 37.6% and in mBCC was 17.4%. Overall ORR by investigator assessment for the 200 mg arm was 56.4% and for the 800 mg arm was 53.4%.
Safety data indicated deaths in both sonidegib arms. In the 200 mg arm, 1.5% of patients with laBCC and 7.7% of patients with mBCC died. In the 800 mg arm, 5.5% of patients with laBCC and 8.7% of patients with mBCC died.
Key figures — cited to the source page
| ORR for sonidegib 200 mg in laBCC (pEAS) | 42.9 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.72 |
| ORR for sonidegib 200 mg in mBCC (pEAS) | 15.4 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.72 |
| ORR for sonidegib 800 mg in laBCC (pEAS) | 37.6 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.72 |
| ORR for sonidegib 800 mg in mBCC (pEAS) | 17.4 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.72 |
| percentage of deaths in sonidegib 200 mg arm (laBCC) | 1.5 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.77 |
| percentage of deaths in sonidegib 200 mg arm (mBCC) | 7.7 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.77 |
| percentage of deaths in sonidegib 800 mg arm (laBCC) | 5.5 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.77 |
| Recommended dose | 200 | Sun Industries B V — Odomzo EMA EPAR public assessment repor, p.10 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.