Orserdu

• Orserdu is an oral selective estrogen receptor degrader (SERD) used for specific advanced breast cancers.
• It targets ER-positive, HER2-negative breast cancer with ESR1 mutations that has progressed after endocrine therapy.
• The medication works by degrading the estrogen receptor, thereby inhibiting cancer cell growth.
• Benefits include improved progression-free survival for eligible patients.
• Common side effects include musculoskeletal pain, nausea, and fatigue; serious side effects require careful monitoring.

What is Orserdu?

Orserdu (elacestrant) is a prescription medication approved for the treatment of postmenopausal women and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer. This targeted therapy is specifically indicated for patients whose disease has progressed after at least one line of endocrine therapy. As a novel oral selective estrogen receptor degrader (SERD), Orserdu offers a new approach for patients whose cancers have developed resistance to standard endocrine treatments, often due to ESR1 mutations.

Understanding Orserdu drug information is crucial for both patients and healthcare providers. It represents a class of drugs designed to directly target and degrade the estrogen receptor, which is a primary driver of growth in ER-positive breast cancers. According to the American Cancer Society, approximately 60% to 70% of breast cancers are hormone receptor-positive and HER2-negative, highlighting the broad relevance of therapies like Orserdu for a significant patient population.

Orserdu: Uses, Benefits, and How It Works

Orserdu is primarily used for treating advanced or metastatic ER-positive, HER2-negative breast cancer that harbors an ESR1 mutation. This mutation is a common mechanism by which breast cancer cells develop resistance to endocrine therapies, making Orserdu a vital option for patients whose disease has progressed despite prior treatments. The medication is an oral formulation, offering convenience compared to injectable SERDs.

The mechanism of action explains how does Orserdu work. Orserdu functions as a selective estrogen receptor degrader. It binds to the estrogen receptor (ER) and induces its degradation, effectively reducing the number of ERs available to promote cancer cell growth. By diminishing ER signaling, Orserdu inhibits the proliferation of ER-positive breast cancer cells. This targeted approach is particularly effective against cancers with ESR1 mutations, which can cause the estrogen receptor to become constitutively active, even in the absence of estrogen, leading to resistance to traditional endocrine therapies.

The Orserdu side effects and benefits profile demonstrates its therapeutic value. A key benefit of Orserdu is its ability to improve progression-free survival (PFS) in the specified patient population compared to standard endocrine therapy. Clinical trials have shown that patients treated with Orserdu experienced a statistically significant and clinically meaningful improvement in PFS. This benefit is particularly pronounced in patients with ESR1 mutations, offering a critical treatment option where other endocrine therapies may have failed. The oral administration also contributes to patient convenience and adherence.

Orserdu Side Effects and Safety Information

Like all medications, Orserdu can cause side effects. Patients should be aware of potential reactions and discuss any concerns with their healthcare provider. Common side effects reported during clinical trials include:

• Musculoskeletal pain
• Nausea and vomiting
• Fatigue
• Increased creatinine levels
• Abdominal pain
• Decreased appetite
• Diarrhea or constipation
• Headache
• Hot flashes
• Stomatitis (inflammation of the mouth)

More serious side effects, though less common, can include hypercholesterolemia (high cholesterol) and hypertriglyceridemia (high triglycerides), which may require monitoring and management. Orserdu can also cause embryo-fetal toxicity, meaning it can harm a developing fetus. Therefore, it is contraindicated in pregnant women, and women of reproductive potential should use effective contraception during treatment and for one week after the last dose. Men with female partners of reproductive potential should also use effective contraception. Patients should inform their doctor about all existing medical conditions and any other medications they are taking to ensure safe and effective treatment with Orserdu.