A Look Back At 2019 FDA Approvals By Cancer Type

December 19, 2019

Over the year, SURVIVEiT® has updated the Newsroom and social media with FDA approvals and notifications relevant to oncology. In case you missed some of the updates, here is a comprehensive look back at all the FDA approvals and notifications in 2019, sorted by cancer type.

It’s important for cancer patients to remember that not all cancer centers have access to all of the latest tests and treatments. Take a look at our Start Here Guide to make sure you’ve taken the two most important steps to see if one of these drugs could be a treatment option for you.

Bladder Cancer

  • Accelerated approval granted to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. (April 2019)

Breast Cancer

  • Trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2 overexpressing breast cancer. (February 2019)
  • Atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. (March 2019)
  • Ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. (May 2019)
  • Alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. (May 2019)

Childhood & Young Adult Cancer

  • Dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. (May 2019)
  • Ruxolitinib (JAKAFI, Incyte Corporation) for  steroid-refractory acute graft-versus-host disease (GVHD) in adult and  pediatric patients 12 years and older. (May 2019)

Endometrial & Uterine Cancer

  • Accelerated approval granted to the combination of pembrolizumab (KEYTRUDA, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. (September 2019)

Esophageal Cancer

  • Pembrolizumab for advanced esophageal squamous cell cancer. (July 2019)

Head & Neck Cancer

  • Pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). (June 2019)

Kidney & Renal Cancer

  • Pembrolizumab (KEYTRUDA, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (April 2019)
  • Avelumab (BAVENCIO, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). (May 2019)

Leukemia

  • Ivosidenib (TIBSOVO, Agios Pharmaceuticals, Inc.) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.  (May 2019)
  • Venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (May 2019)
  • FDA approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. (May 2019)
  • Fedratinib (INREBIC, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). (August 2019)
  • Acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (November 2019)

Liver Cancer

  • Cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. (January 2019)
  • Ramucirumab (CYRAMZA, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib. (May 2019)

Lung Cancer​

  • Atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small-cell lung cancer (ES-SCLC). (March 2019)
  • Pembrolizumab (KEYTRUDA, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test. (April 2019)
  • FDA granted accelerated approval to pembrolizumab (KEYTRUDA,  Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. (June 2019)
  • Atezolizumab (TECENTRIQ, Genentech  Inc.) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.(December 2019)

Lymphoma

  • Venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (May 2019)
  • Lenalidomide (REVLIMID, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously-treated marginal zone lymphoma (MZL). (May 2019)
  • FDA granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. (June 2019)
  • Accelerated approval granted to zanubrutinib (BRUKINSA, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (November 2019)
  • Acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (November 2019)

Melanoma

  • Pembrolizumab (KEYTRUDA, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. (February 2019)

Myeloma

  • Daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (June 2019)
  • Accelerated approval granted to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. (July 2019)
  • Daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). (September 2019)

Ovarian Cancer

  • Niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HDR is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy. (October 2019)

Prostate Cancer

  • Darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. (July 2019)
  • Apalutamide (ERLEADA, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. (September 2019)
  • Enzalutamide (XTANDI, Astellas Pharma Inc.) approved for patients with metastatic castration-sensitive prostate cancer (mCSPC). (December 2019)

Stomach Cancer

  • Trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. (February 2019)

Adult & Pediatric Patients

  • Accelerated approval granted to entrectinib (ROZLYTREK, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. (August 2019)
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