FDA was approved to | annual inventory (middle) of breast cancer and gynecologic oncology

breast cancer

1

August 5, 2022

On August 5, 2022, the U.
S.
Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan nxki (DS-8201, T-DXd) for the treatment of unresectable or metastatic HER2-hypoexpressive adult breast cancer patients who have previously been treated for metastatic disease or who have relapsed
within 6 months of adjuvant therapy.

The approval is based on the DESTINY-Breast04 study, please click on the link to see the approval details: Summer Stocktaking | From June to August, the FDA list of drugs and regimens approved in the field of solid
tumors.

The recommended dose of T-Dxd is 5.
4 mg/kg, q3 W until disease progression or toxicity is intolerable
.

2

May 4, 2022

On May 4, 2022, the U.
S.
Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan nxki (DS-8201, T-DXd) for patients with unresectable or metastatic HER2-positive adult breast cancer who had received anti-HER2 therapy in prior systemic therapy or anti-HER2 therapy in neoadjuvant or adjuvant therapy and developed disease recurrence during treatment or within 6 months of completion of treatment
。

T-DXd received accelerated approval in December 2019 for patients with unresectable or metastatic HER2-positive adult breast cancer who received ≥ two anti-HER2 therapies
in prior systemic therapy.

The approval is based on the DESTINY-Breast03 study, click on the link to see the approval details: FDA Alert| FDA approves T-DXd (DS-8201) for second- and later-line treatment
of breast cancer.

For breast cancer patients, the recommended dose of T-DXd is 5.
4 mg/kg intravenous infusion every 3 weeks until disease progression or intolerability
of toxicity.

3

March 11, 2022

On March 11, 2022, the FDA approved Orapa for adjuvant therapy
in adult patients with HER2-negative HER2-negative high-risk early-stage breast cancer who had previously received neoadjuvant or adjuvant chemotherapy.
Patients must be screened for olaparib for
FDA-approved companion diagnostics.

The approval is based on the OlympiA study, click the link to see the approval details: FDA Alert| Overview of FDA approvals in oncology in early March
.

The recommended dose of olaparib is 300 mg orally twice daily with or without meals for one year
.

Gynecologic tumors

1

November 14, 2022

On November 14, 2022, the FDA accelerated approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor α (FRα) positive and platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had previously received 1- to 3 lines of systemic therapy, based on the SORAYA (NCT04296890) study
.

This accelerated approval is based on the SORAYA study, details of which can be found at FDA Alert | A summary
of FDA oncology approvals in November.

According to the adjusted ideal body weight (AIBW), the recommended dose of mirvetuximab soravtansine-gynx is 6 mg/kg, IV, q3w until disease progression or toxicity is intolerable
.

2

March 21, 2022

On March 21, 2022, the FDA approved pembrolizumab monotherapy for the treatment of advanced endometrial cancer patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) who have progressed to disease after prior systemic therapy and are not candidates for therapeutic surgery or radiotherapy
.

The approval is based on the KEYNOTE-158 study, please click on the link to see the approval details: FDA Alert| List of FDA approvals in oncology in mid-March
.

The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, toxicity intolerance, or treatment for up to 24 months
.