Coronavirus Doesn’t Halt Cancer Drug Approvals

53 Innovative Cancer Drugs Received FDA Approval in 2020

Amid emergency use authorizations for COVID-19 vaccines, treatments and at-home rapid tests, the U.S. Food and Drug Administration (FDA) approved 53 new drugs in 2020. This is the second-highest number in more than 20 years and an increase from 48 new drugs in 2019.

Of the drugs and biological products on the FDA’s Center for Drug Evaluation and Research “Novel Drug Approvals for 2020” list, there were several innovative drugs for cancer, including:

• Two for prostate cancer,

• Four for breast cancer,

• Nine for non-small cell lung cancer (NSCLC); two of which were also approved to treat patients with certain types of thyroid cancer,

• Two for small cell lung cancer (SCLC),

• Three for multiple myeloma.

We’ve outlined several of the new treatments below, broken down by cancer type. This list includes novel drugs as well as new and expanded uses of existing medications.

PROSTATE CANCER

Drug: Lynparza (olaparib) tablets
Approval Date: May 19
Significance: Approved to treat homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). HRR gene mutations occur in approximately 20-30% of patients with mCRPC. Lynparza was originally approved in capsule form in 2014 to treat certain patients with a type of ovarian cancer.

Drug: Orgovyx (relugolix)
Approval Date: December 18
Significance: The first and only oral hormone therapy for treating advanced prostate cancer, a plus for men who may be unable to travel for injections because of COVID-19. Orgovyx reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. It is expected to be available this month.

BREAST CANCER

Drug: Tukysa (tucatinib)
Approval Date: April 17
Significance: Tukysa was approved in combination with Herceptin (trastuzumab) and Xeloda (capecitabine) to treat metastatic HER2-positive breast cancer or locally advanced (has spread to tissue near the breast but not the body) HER2-positive disease that can’t be completely removed with surgery. It is a second-line treatment.

Drug: Trodelvy (sacituzumab govitecan-hziy)
Approval Date: April 22
Significance: Trodelvy was approved for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies. While chemotherapy has been the standard of care for TNBC, Trodelvy represents a new targeted therapy for this aggressive form of breast cancer.

Drug: Phesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf)
Approval Date: June 28
Significance: Phesgo, a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf, was approved for subcutaneous injection to treat early and metastatic HER2-positive breast cancer. Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the patient is done with chemo.

Drug: Margenza (margetuximab-cmkb) 
Approval Date: December 16
Significance: Margenza was approved in combination with chemotherapy to treat metastatic HER2-positive breast cancer in patients who have received two or more anti-HER2 treatments, at least one of which was for metastatic disease. Margenza attaches to the HER2 receptors on the surface of breast cancer cells and blocks them from receiving growth signals. This can slow or stop the growth of the breast cancer.

LUNG CANCER

Drug: Opdivo (nivolumab) and Yervoy (ipilimumab)
Approval Date: March 11
Significance: The injectable products were approved for use in combination to treat patients with non-small cell lung cancer (NSCLC). Opdivo was originally approved in 2014 for the treatment of certain patients with metastatic squamous NSCLC. Yervoy was first approved in 2011 for the treatment of patients with unresectable or metastatic melanoma.

Drug: Imfinzi (durvalumab)
Approval Date: March 27
Significance: Imfinzi was approved in combination with certain types of chemotherapy for the first-line treatment of adult patients with extensive-stage small-cell lung cancer (SCLC). Imfinzi was originally approved in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.

Drug: Tabrecta (capmatinib)
Approval Date: May 6
Significance: Tabrecta was approved to treat adult patients with metastatic NSCLC. Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skippings). METex14 has been linked to cancer growth in metastatic NSCLC.

Drug: Retevmo (selpercatinib)
Approval Date: May 8
Significance: Retevmo was approved to treat NSCLC, medullary thyroid cancer, and other types of thyroid cancers with rearranged during transfection (RET) mutations. About 2% of patients with NSCLC have tumors in which a piece of the RET gene is fused to part of another gene. This results in the production of abnormal RET proteins, which spur the growth of cancer cells. Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.

Drug: Tecentriq (atezolizumab)
Approval Date: May 18
Significance: Tecentriq was approved as a first-line treatment for patients with metastatic NSCLC whose tumors have a protein called programmed death-ligand 1, or PD-L1, which is found on many cells, including cancer cells. PD-L1 on cancer cells can bind to immune cells, preventing the immune system from being able to recognize and attack the cancer. Tecentriq was originally approved in 2016 to treat certain patients with metastatic urothelial carcinoma (a type of bladder cancer).

Drug: Alunbrig (brigatinib)
Approval Date: May 22
Significance: Alunbrig was approved for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC. Approximately three to five percent of patients with metastatic NSCLC have a rearrangement in the ALK gene, which is responsible for the growth and spread of ALK+ NSCLC. Alunbrig is designed to target these ALK molecular alterations.

Drugs: Cyramza (ramucirumab) and Tarceva (erlotinib)
Approval Date: May 29
Significance: Cyramza injection and Tarceva tablets were approved as a first-line treatment for patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Cyramza was originally approved in 2014 for the treatment of certain patients with either of two types of stomach cancer following chemotherapy. Tarceva was originally approved in 2004 for the treatment of locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen.

Drug: Zepzelca (lurbinectedin)
Approval Date: June 15
Significance: Zepzelca was approved to treat adults with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy. SCLC accounts for about 10% to 15% of lung cancer cases. Zepzelca was the first new drug approved for second-line treatment of SCLC since 1996.

Drug: Gavreto (pralsetinib)
Approval Date: September 4
Significance: Gavreto became the second RET inhibitor approved to treat RET-mutated NSCLC, following the approval of Retevmo. On Dec. 1, the indication was expanded to include advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.

MULTIPLE MYELOMA

Drug: Sarclisa (isatuximab-irfc)
Approval Date: March 2
Significance: Sarclisa was approved in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revilimid) and a proteasome inhibitor. It works by helping certain cells in the immune system to attack multiple myeloma cancer cells.

Drug: Darzalex Faspro (daratumumab and hyaluronidase-fihj)
Approval Date: May 1
Significance: Darzalex Faspro was approved to treat patients with relapsed or refractory multiple myeloma; it is injected under the skin into the abdomen over approximately 3 to 5 minutes, according to the recommended schedule. The new approval represents a significant advantage over the original formulation of Darzalex (daratumumab without hyaluronidase-fihj), which required an intravenous infusion given over several hours.

Drug: Blenrep (belantamab mafodotin-blmf)
Approval Date: Aug. 5
Significance: A “first-in-class" treatment for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies. Blenrep is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world. BCMA is a protein found on the surface of myeloma cells and is a target for many therapies.

DIFFUSE LARGE B-CELL LYMPHOMA 

Drug: Monjuvi (tafasitamab-cxix)
Approval Date: July 31
Significance: Monjuvi was approved to treat adults with diffuse large B-cell lymphoma (DLBCL) whose disease has come back or has not improved after previous treatments. It is for patients who cannot receive a stem cell transplant. It was approved in combination with Revlimid (lenalidomide).

If you have questions about any of the drugs listed above, please ask your doctor. For the complete list, visit “Novel Drug Approvals for 2020.”

(Note: CDER’s list does not include vaccines, allergenic products, blood and blood products, plasma derivatives, or cellular and gene therapy products or other products approved in 2020 by the Center for Biologics Evaluation and Research.)