Pamiparib(帕米帕利胶囊)

Introduction of Pamiparib

Pamiparib Capsules were granted conditional approval for marketing by the National Medical Products Administration (NMPA) of China on May 7, 2021. Prior to this, its new drug application (NDA) had been included in the priority review process and supported by the National Major New Drug Creation Program.

Indications

Pamiparib Capsules are indicated for the treatment of adult patients with recurrent advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have germline BRCA (gBRCA) mutations and have received second-line or later-line chemotherapy.

This indication was granted conditional approval based on the results of an open-label, multicenter, single-arm, phase II clinical trial involving 113 patients with recurrent advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who had gBRCA mutations and had received second-line or later-line chemotherapy previously. The full approval of this indication will depend on the confirmation of clinical benefit of this product in the aforementioned patient population by ongoing confirmatory trials.

Overview

Dosage and Administration

This product must be administered under the guidance of physicians experienced in anti-tumor therapy.

BRCA Mutation Testing

Before initiating treatment with this product, harmful or suspected harmful germline BRCA (gBRCA) mutations in patients must be confirmed using detection methods approved by the National Medical Products Administration (NMPA) of China before treatment can be started.

Recommended Dose

The recommended dose is 60 mg (3 capsules) per dose, twice daily, equivalent to a total daily dose of 120 mg. Treatment should be continued until disease progression or unacceptable adverse reactions occur.

Administration Method

It is recommended that patients take the medication orally at approximately the same time each day. The capsules must be swallowed whole and should not be chewed, crushed, dissolved, or opened. This product may be taken with or without food.

Missed Dose

If a patient vomits or misses a dose, an extra dose should not be taken. The next scheduled dose should be taken as planned.

Contraindications

1.Patients with hypersensitivity to the active pharmaceutical ingredient of Pamiparib or any of its excipients are prohibited from use.

2.Breastfeeding must be discontinued during treatment and within 1 month after the last dose.

Adverse Reactions

Adverse reactions include the following:

1.Adverse reactions: anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, decreased appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) elevation, alanine aminotransferase (ALT) elevation, blood bilirubin elevation, and lymphopenia.

2.Grade 3 and above adverse reactions: anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, nausea, and AST elevation.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

It is not recommended that women of childbearing potential become pregnant at the initiation of and during treatment with this product. A pregnancy test is required for all such women prior to the start of treatment.

Women of childbearing potential must take effective contraceptive measures during treatment and within 6 months after the last dose of this product.

Pregnancy

Based on its mechanism of action and non-clinical toxicology study results, pamiparib may cause harm to the embryo/fetus. There are no data available on the use of this product in pregnant women, and thus drug-related risks cannot be reported. Pregnant women should be informed that this product may cause fetal harm and has a potential risk of miscarriage.

Lactation

It is unknown whether pamiparib is excreted in human milk or its effects on milk production in breastfeeding mothers. Since breastfed infants may experience adverse reactions due to exposure to this product, lactating women must discontinue breastfeeding during treatment with pamiparib and within 1 month after the last dose.

Fertility

There is no information available on the effects of this product on human fertility. In 3-month repeated-dose general toxicology studies in animals, no treatment-related macroscopic lesions or histopathological abnormalities were observed in the reproductive organs of male and female animals.

Use in Pediatric Patients

The safety and efficacy of this product in patients under 18 years of age have not been established.

Use in Elderly Patients

Among 256 patients who received monotherapy with pamiparib at a dose of 60mg twice daily, 31 patients(12.1%) were aged ≥ 65 years, including 3 patients(1.2%) aged ≥ 75 years. No special dose adjustment was made for elderly patients in clinical studies. There were no significant differences in the safety and efficacy data of pamiparib treatment between younger and elderly patients.

For more detailed drug information, please consult the official package leaflet.

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