Everything you need to know about Selpercatinib

What is Selpercatinib?

Selpercatinib is an oral medication to treat thyroid and lung cancers with RET gene alterations. It is sold under the brand name Retevmo. This drug was approved by the US Food and Drug Administration (FDA) in May 2020. However, it is still under clinical trials for investigation of specific RET-driven cancer indications.

Selpercatinib is a selective inhibitor of RET kinase that affects tumor cells as well as the healthy ones. In spite of being an approved cancer drug, this behavior of affecting the healthy cells has led the results with many side effects. Though the medication is approved, further studies and clinical trials are conducted to come up with a stable formulation that doesn’t damage the healthy cells.

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What is the chemical structure of Selpercatinib?

Selpercatinib is a white to light yellow powder with molecular formula C29H31N7O3. The IUPAC name is 6-(2-hydroxy-2-methylpropoxy)-4- (6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3- yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, and the chemical structure can be depicted as:

Selpercatinib

It is a slightly hygroscopic compound with molecular weight of 525.61 g/mol. Its solubility in water is dependent of pH, which is easily soluble at a lower pH whereas the solubility moves towards slightly or sparingly soluble at neutral of higher pH.

Medical uses of Selpercatinib?

  • Selpercatinib is a kinase inhibitor indicated for the treatment of various types of cancer
  • It is used to treat non-small cell lung cancer (NSCLC) in adults, which has already spread across the body
  • It is used to treat metastatic medullary thyroid cancer in adults and children of 12 and above
  • It is used to treat metastatic thyroid cancer in adults and children of 12 and above, who do not show any improvement with radioactive iodine

Selpercatinib – Dosage

Selpercatinib is sold under the brand Retevmo , which is available as 40mg and 80g hard gelatin capsules for oral use. Each capsule consists of inactive ingredients of microcrystalline cellulose and colloidal silicon dioxide.  Titanium dioxide, gelatin, ferric oxide black and black ink are the primary ingredients of the 40mg capsule; however, the 80mg one consists of FD&C blue #1 and black ink, in addition to gelatin and titanium oxide. In selpercatinib production, the black ink used is made up of shellac, potassium hydroxide and ferric oxide black.

Dosage in adults

In case of non-small cell lung cancer (NSCLC), indicated for metastatic RET fusion-positive NSCLC, the dosage would be 120mg twice a day for a person with body weigh less than 50 kg, and 160mg twice a day for more than 50mg body weight.

In patients who suffer from Medullary Thyroid Cancer and require systemic therapy, the dosage should be 120mg twice a day for person with less than 50kg and 160mg for more than or equal to 50kg body weight.

For Thyroid cancer in adults, the same dosage as above is recommended. The medication should be discontinued until disease progression, or there is any unacceptable toxicity noticed. This is a general dosage of the medicine; it should be strictly consumed as per the instructions and recommendations by the doctor.

Dosage in pediatrics

In children, selpercatinib is used to treat Medullary Thyroid Cancer and Thyroid Cancer. The safety and efficacy parameters are not established for kids below 12 years, hence, this medication cannot be used by the defined age group. For kids of 12 years and above, it can used twice a day, 120mg for less than 50mg individual and 160mg for the ones more than that.

What are the side effects of Selpercatinib

Retevmo comes with a set of side effects, the most common ones include:

  • Dry mouth, rashes, diarrhea, constipation
  • Tiredness and fatigue
  • Increased blood sugar levels
  • High blood pressure
  • Decrease in white blood cell count
  • Increased levels of liver enzymes
  • Decreased protein levels (albumin) in the blood
  • Decreased levels of calcium in the blood
  • Increased creatinine (kidney function test)
  • Swelling of your arms, legs, hands, and feet (peripheral edema)
  • Decrease in platelet count
  • Increased cholesterol levels
  • Decreased levels of salt (sodium) in the blood

Top Manufacturers of Selpercatinib

Selpercatinib is the first therapy, approved by US FDA last year, for treatment of patients with advanced RET-driven lung and thyroid cancers. Commercially sold over the name Retevmo, it was developed by Eli Lilly and Company, Loxo Oncology. The medication is available in various countries and sold through specialty pharmacies under the prescription of the doctor. Further clinical studies are being conducted on Retevmo  to reduce the side effects.

The RET-inhibitor is commercially available and has recorded a market opportunity of about $1.5 billion this year. Retevmo Selpercatinib is expected to be more stable in the coming year and the commercialization is expected to grow multiple folds. As per a recent report, the global market is expected to exceed $2 billion by 2025.

Where to buy Selpercatinib in India?

Being among one of the world’s largest chemical industries, the Indian chemical industry still follows the conventional way of buying chemicals directly from a manufacturer, supplier, or a third-party dealer. Buyers usually have a long-term agreement with suppliers/manufacturers/dealers, or reach out to new suppliers when the required chemical are not available elsewhere. This trend is based on the trust, where buyers are usually in good business relationship with the supplier; such business relations take decades to achieve. However, this cannot fit in the modern world where technology is changing every single day. Thousands of new chemical formulations make into the CAS Registry every day, and also the chemical requirement of the buyers is rapidly changing. To suit this modern era, the Indian chemical industry is adapting to the new-age trend of digitization.

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