FDA Approves Pembrolizumab for High-Risk, Early-Stage, Triple-Negative Breast Cancer
On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery.
Oncology Drug Reference Sheet: Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf Subcutaneous Injection
Pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (PhesgoTM) was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for patients with advanced HER2-positive breast cancer. The drug components are the same as those in FDA-approved IV version, and study results showed comparable safety and efficacy to the IV counterparts. The new administration route allows eligible patients to bypass infusion centers or even receive the therapy at home.
FDA Grants Regular Approval to Enfortumab Vedotin-Ejfv for Locally Advanced or Metastatic Urothelial Cancer
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv ([EV], Padcev®), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Oncology Drug Reference Sheet: Tepotinib
Tepotinib (Tepmetko®) was granted accelerated approval in February 2021 for mesenchymalepithelial transition (MET)-altered metastatic non-small cell lung cancer (NSCLC) based on overall response rate and duration. The drug is still under long-term evaluation and healthcare providers should report all serious adverse events that may be associated to FDA’s MedWatch Reporting System.
Oncology Drug Reference Sheet: Trilaciclib
On February 12, 2021, the U.S. Food and Drug Administration approved trilaciclib (CoselaTM), a parenteral inhibitor of cyclin-dependent kinase, to prevent myelosuppression when administered prior to chemotherapy administration. The approval is currently limited to the use of trilaciclib before treatment with platinum- and etoposide-containing regimens and topotecan-containing regimens for treatment of extensive-stage small cell lung cancer.
Oncology Drug Reference Sheet: Tafasitamab-Cxix
Tafasitamab-cxix (Monjuvi®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.
Oncology Drug Reference Sheet: Alpelisib
When used in combination with fulvestrant, alpelisib (Piqray®) produced complete or partial responses in 29% of patients with PIK3CA-altered, estrogen receptor-positive advanced breast cancer in clinical trials. The U.S. Food and Drug Administration approved it for use in 2019.
Oncology Drug Reference Sheet: Selpercatinib
In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.
Oncology Drug Reference Sheet: Lurbinectedin
In June 2020, the U.S. Food and Drug Administration granted accelerated approval to lurbinectedin (ZepzelcaTM) for adults with metastatic small cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. The approval adds a second choice for patients who experience treatment-resistant SCLC progression, who previously had only topotecan as an option.
Oncology Drug Reference Sheet: Zanubrutinib
Zanubrutinib (BrukinsaTM) received U.S. Food and Drug Administration accelerated approval on November 14, 2019, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Oncology Drug Reference Sheet: Rucaparib
Rucaparib (Rubraca®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.
Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.
Oncology Drug Reference Sheet: Capecitabine
Capecitabine (Xeloda®) was approved by the U.S. Food and Drug Administration (FDA) in 1998 as a nucleoside metabolic inhibitor with antineoplastic activity indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.
Oncology Drug Reference Sheet: Daratumumab
Daratumumab (Darzalex®) was originally approved by the U.S. Food and Drug Administration in 2015 with additional indications added since. The most recent new indication was approved in September 2019 for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplantation. In May 2020, daratumumab and hyaluronidase-fihj (Darzalex Faspro™), a subcutaneous (SQ) formulation, was approved.
Oncology Drug Reference Sheet: Tocilizumab
Tocilizumab was approved in August 2017 for the treatment of chimeric antigen receptor T cell–induced cytokine release syndrome. In March 2020, the U.S. Food and Drug Administration approved a randomized, double-blind, placebo-controlled, phase III clinical trial to assess the safety and efficacy of tocilizumab plus standard of care in patients hospitalized with severe COVID-19 pneumonia.
Oncology Drug Reference Sheet: Panitumumab
Approved in 2006 as monotherapy for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) after disease progression following treatment, panitumumab has been a mainstay metastatic disease for more than a decade. In 2014, it received additional indication as first-line therapy for the treatment of patients with EGFR-expressing mCRC in combination with FOLFOX, but in 2017, use was narrowed to wild-type RAS (not mutated RAS).
Oncology Drug Reference Sheet: Entrectinib
Entrectinib was approved by the U.S. Food and Drug Administration in August 2019 as the third tumor-agnostic cancer drug, meaning it targets a specific mutation of the cancer, not the organ of origin. The other two currently approved tumor-agnostic drugs are larotrectinib and pembrolizumab.
Oncology Drug Reference Sheet: Blinatumomab
Blinatumomab received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of B-cell precursor acute lymphoblastic leukemia. The drug’s unique administration procedures have prompted nurses to evaluate their practice for safety.
Oncology Drug Reference Sheet: Darolutamide
Based on the results of the phase III ARAMIS trial that demonstrated significant improvement in metastasis-free survival, the U.S. Food and Drug Administration approved darolutamide under priority review on July 30, 2019. Darolutamide is approved for nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy.
Oncology Drug Reference Sheet: Venetoclax
Venetoclax (Venclexta®) was approved by the U.S. Food and Drug Administration on May 15, 2019, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a single agent or in combination therapy. Previously, it had been approved in late 2018 for use in combination therapy for acute myeloid leukemia (AML) in older adults or those with significant comorbidities.
Oncology Drug Reference Sheet: Atezolizumab’s Indications for Breast and Lung Cancer
The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.
Oncology Drug Reference Sheet: Combination Trastuzumab and Hyaluronidase-Oysk
A new product that combines trastuzumab and hyaluronidase (Herceptin Hylecta™) received U.S. Food and Drug Administration approval in February 2019 for the treatment of HER2-overexpressing breast cancer. The approval was based on the results of two randomized trials: HannaH and SafeHER.
Oncology Drug Reference Sheet: Talazoparib
Initially approved in 2018, talazoparib (Talzenna®) capsules are indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene HER2-negative locally advanced or metastatic breast cancer.
Oncology Drug Reference Sheet: Cabozantinib
Cabozantinib (Cabometyx®) received an additional U.S. Food and Drug Administration (FDA)-approved indication in January 2019 for use in patients with hepatocellular carcinoma (HCC) who have already been treated with sorafenib. It received prior approval for the treatment of renal cell carcinoma in 2017. The research leading to the approval in the HCC setting showed improved overall survival, progression-free survival, and overall response in the cabozantinib treatment arm.
Oncology Drug Reference Sheet: Glasdegib
In November 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo™) for use in combination with low-dose cytarabine for treatment of patients with newly diagnosed acute myeloid leukemia who are not eligible for intensive chemotherapy. Data from clinical trials indicated that the regimen is safe for older adults and those with significant comorbidities, such as cardiac disease, poor performance status, or elevated serum creatinine.
Oncology Drug Reference Sheet: Ribociclib
Ribociclib is a CDK 4/6 inhibitor first approved by the U.S. Food and Drug Administration in early 2017 for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy, based on the MONALEESA trial results.
Oncology Drug Reference Sheet: Lutetium Lu 177 Dotatate
Lutetium Lu 177 dototate (Lutathera®) was approved in January 2018 by the U.S. Food and Drug Administration to treat a specific group of neuroendocrine tumors (NETs) in the gastrointestinal tract. NETs are rare, and the tumors produce hormone-like substances in response to signals from the nervous system.