Odomzo (sonidegib) vs Mektovi (binimetinib)

Odomzo (sonidegib) is a medication specifically approved for the treatment of locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or for patients who are not candidates for these therapies. It works by inhibiting the Hedgehog signaling pathway, which is active in BCC. On the other hand, Mektovi (binimetinib) is a MEK inhibitor used in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, targeting a different pathway than Odomzo. When deciding between these two medications, it is essential to consider the type of skin cancer, the presence of specific genetic mutations, and the overall health profile of the patient.

Difference between Odomzo and Mektovi

Metric	Odomzo (sonidegib)	Mektovi (binimetinib)
Generic name	Sonidegib	Binimetinib
Indications	Locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or for those who are not candidates for surgery or radiation therapy.	Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with encorafenib.
Mechanism of action	Hedgehog pathway inhibitor	MEK inhibitor, which inhibits mitogen-activated protein kinase (MAPK)/extracellular signal-regulated kinase (ERK) signaling
Brand names	Odomzo	Mektovi
Administrative route	Oral	Oral
Side effects	Muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, decreased weight, decreased appetite, diarrhea, vomiting, myalgia, abdominal pain, headache.	Acneiform dermatitis, increased creatine phosphokinase, hypertension, increased aspartate aminotransferase, increased alanine aminotransferase, hyperglycemia, nausea, vomiting, abdominal pain, constipation, fatigue, decreased appetite, arthralgia, rash.
Contraindications	None known.	None known.
Drug class	Smoothened (SMO) inhibitor	MEK inhibitor
Manufacturer	Sun Pharmaceutical Industries, Inc.	Array BioPharma Inc. (a subsidiary of Pfizer Inc.)

Efficacy

Odomzo (Sonidegib) Efficacy in Treating Skin Cancer

Odomzo (sonidegib) is a medication that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. BCC is the most common form of skin cancer, and while it is generally slow-growing, it can become invasive and difficult to treat if not addressed early.

Clinical trials have demonstrated the efficacy of Odomzo in shrinking or eliminating tumors in a significant proportion of patients with advanced BCC. In a pivotal phase II study, known as the BOLT study, patients treated with Odomzo showed an objective response rate (ORR) that was compelling, with some patients experiencing a complete response. The duration of response also supported the therapeutic potential of Odomzo, with many patients maintaining a response for six months or longer, which is particularly noteworthy considering the advanced stage of disease in the study population.

Mektovi (Binimetinib) Efficacy in Treating Skin Cancer

Mektovi (binimetinib) is another medication that has been approved for use in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Melanoma is a more aggressive form of skin cancer compared to BCC and has a higher potential to spread to other parts of the body. The combination of Mektovi with encorafenib targets specific genetic mutations within melanoma cells to inhibit tumor growth.

The approval of Mektovi was based on a phase III clinical trial known as the COLUMBUS trial, which demonstrated a significant improvement in progression-free survival (PFS) for patients treated with the combination of Mektovi and encorafenib compared to those treated with vemurafenib monotherapy. The combination therapy not only extended the time patients lived without their disease progressing but also showed an improvement in overall survival (OS), making it a valuable treatment option for patients with BRAF-mutant melanoma.

Regulatory Agency Approvals

Odomzo

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Therapeutic Goods Administration (TGA), Australia

Mektovi

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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