Trodelvy ( sacituzumab govitecan-hziy)

What is Trodelvy (sacituzumab govitecan-hziy) for?

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor antibody-drug conjugate (ADC) for patients with previously-treated metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. It is available in vial form each containing 180 mg of sacituzumab govitecan-hziy.¹

How does Trodelvy (sacituzumab govitecan-hziy) work?

Sacituzumab govitecan-hziy is a Trop-2-directed ADC. The molecule is made up of 3 parts:²

1. Sacituzumab, a Trop-2-recognizing antibody, which is a type of protein designed to recognise and attach to the Trop2 antigen present on cancer cells.
2. SN-38, a topoisomerase I inhibitor, which damages the tumor cell’s DNA and inhibits further DNA replication.
3. A compound that conjugates (links) these two parts together.

When sacituzumab binds to Trop-2 on the cancer cell, the drug is taken up by the cell and the linker is cleaved subsequently, releasing SN-38. SN-38 then causes the destruction of Trop-2-positive cancer cells.^1,2

Where has Trodelvy (sacituzumab govitecan-hziy) been approved?

Trodelvy (sacituzumab govitecan-hziy) was approved for the treatment of patients with previously-treated mTNBC by the Food and Drug Administration (FDA), USA, April 22, 2020, under accelerated approval.²

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designation, to aid in the development of therapies to treat serious conditions and to fill an unmet medical need.²

Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.³

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Trodelvy (sacituzumab govitecan-hziy) taken?

The standard dosage is:¹

• 10 mg/kg administered as an intravenous infusion once per week on days 1 and 8 of 21-day treatment cycles.

Continue treatment until disease progression or unacceptable toxicity.

The first infusion is administered over 3 hours. If the initial infusion is well tolerated, subsequent infusions can be administered over 1 to 2 hours.¹

Complete information about Trodelvy (sacituzumab govitecan-hziy) dosage and administration can be found in the official prescribing information listed in our references section.¹

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known adverse reactions or side effects of Trodelvy (sacituzumab govitecan-hziy)?

Common adverse reactions

The most common adverse reactions (>25% of patients) listed in the prescribing information include:¹

• Nausea
• Diarrhea
• Fatigue
• Anemia
• Vomiting
• Alopecia
• Constipation
• Rash
• Decreased appetite
• Abdominal pain

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:¹

• Low white blood cell count (neutropenia)
• Anemia
• Hypophosphatemia
• Severe diarrhea

Use in specific populations

Trodelvy (sacituzumab govitecan-hziy) can be fatal for a foetus, it is advised to avoid pregnancies and breastfeeding.¹

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.¹

References

1. Full prescribing information [FDA]: Trodelvy (sacituzumab govitecan-hziy) [PDF]
Immunomedics, Inc.

2. FDA Approves New Therapy for Triple Negative Breast Cancer
FDA press release, April 22, 2020

3. FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer
Drugs News, April 22, 2020