These FDA approvals display a relentless pursuit of innovation in oncology, empowering oncologists with increasingly sophisticated treatment to help navigate and manage cancer’s complexities.
As we approach the close of 2023, we reflect on the remarkable strides made in the landscape of oncology treatments and approved by the FDA this year. Approvals in hematologic malignancies such as talquetamab-tgvs(Talvey) and elranatamab-bcmm (Elrexfio) in relapsed/refractory multiple myeloma, and approvals for dostarlimab (Jemperli) and fruquintinib (Fruzaqla) in endometrial cancer and colorectal cancer, respectively, mark significant advancements in the field.
The following approvals help determine the path toward more tailored and effective treatments, and the expansion of therapeutic options adds diversification of strategies but also adds multidisciplinary collaboration in delivering optimal care. These FDA approvals display a relentless pursuit of innovation in oncology, empowering oncologists with increasingly sophisticated treatment to help navigate and manage cancer’s complexities.
JANUARY 27: The FDA approves elacestrant (Orserdu), an oral selective estrogen receptor degrader, for use in patients with estrogen receptor– positive/HER2-negative advanced or metastatic breast cancer.
FEBRUARY 3: Sacituzumab govitecan-hziy (Trodelvy) received FDA approval for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/in situ hybridization–negative) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
NOVEMBER 16: The FDA has granted approval to the combination of capivasertib (Truqap) and fulvestrant (Faslodex) for the treatment of adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer that harbors 1 or more PIK3CA, AKT1, or PTEN alterations as detected by an FDA-approved test following progression on 1 or more endocrine-based regimens in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
JANUARY 26: The FDA approves adjuvant pembrolizumab (Keytruda) following resection and platinum-based chemotherapy for stage IB (T2a ≥ 4 cm), II, or IIIA non–small cell lung cancer (NSCLC).
AUGUST 9: The FDA approves the RET tyrosine kinase inhibitor pralsetinib (Gavreto) for the treatment of adult patients with metastatic RET fusion–positive NSCLC as detected by an FDA-approved test.
OCTOBER 11: The FDA approves the combination of encorafenib (Braftovi) and binimetinib (Mektovi) for patients with metastatic NSCLC harboring a BRAF V600E mutation, as detected by an FDA-approved test.
OCTOBER 16: The FDA approves perioperative pembrolizumab
(Keytruda) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent in the adjuvant setting for the treatment of patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC.
NOVEMBER 15: The FDA has granted approval to repotrectinib (Augtyro), a tyrosine kinase inhibitor, for the treatment of patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer.
JANUARY 19: The FDA approves the Bruton tyrosine
kinase (BTK) inhibitor zanubrutinib (Brukinsa) for adult patients with chronic lymphocytic leukemia or small lymphocytic
JANUARY 27: The FDA approves pirtobrutinib (Jaypirca)
for the treatment of adult patients with relapsed/refractory mantle cell lymphoma who previously received at least 2 lines of systemic therapy, including a BTK inhibitor.
MARCH 7: The FDA approves nelarabine (Arranon) injection for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
APRIL 17: The FDA approves omidubicel-onlv (Omisirge) as a treatment for patients 12 years and older with blood cancers with hematologic malignancies who are scheduled for umbilical cord blood transplantation after myeloablative conditioning.
APRIL 19: The FDA approves polatuzumab vedotin-piiq (Polivy) in combination with rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
MAY 22: The FDA approves avapritinib (Ayvakit) as a treatment option for adult patients with indolent systemic mastocytosis.
JUNE 15: The FDA grants accelerated approval to glofitamab-gxbm (Columvi) for adult patients with relapsed/refractory DLBCL not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after at least 2 lines of systemic therapy.
JUNE 21: The FDA grants full approval to blinatumomab (Blincyto) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1%.
JULY 20: The FDA approves the combination of quizartinib (Vanflyta) and standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia with FLT3 internal tandem duplication.
AUGUST 10: The FDA grants accelerated approval to talquetamab-tgvs (Talvey), a first-in-class bispecific antibody for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
AUGUST 14: The FDA grants accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with RRMM who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, according to Pfizer, Inc, in a news release.
AUGUST 28: The FDA approves luspatercept-aamt (Reblozyl) for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions. This approval expands the use of luspatercept to the frontline setting.
SEPTEMBER 11: The FDA approves motixafortide (Aphexda) in combination with filgrastim granulocyte colony-stimulating factor, a compound therapy intended to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
SEPTEMBER 15: The FDA approves momelotinib (Ojjaara) for the treatment of patients with myelofibrosis and anemia.
SEPTEMBER 26: The FDA approves bosutinib (Bosulif) for the treatment of pediatric patients 1 year or older with chronic phase Ph+ chronic myeloid leukemia that is newly diagnosed or resistant or intolerant to prior therapy.
OCTOBER 24: The FDA approves ivosidenib (Tibsovo) tablets for adult patients with relapsed/refractory MDS with a susceptible IDH1 mutation, as detected by an FDA-approved test.
FEBRUARY 9: The FDA approves dostarlimab (Jemperli) for the treatment of patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
APRIL 3: The FDA approves the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
MAY 30: The FDA approves flotufolastat F 18 injection (Posluma; formerly 18F-rhPSMA-7.3) for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
MAY 31: The FDA approves olaparib (Lynparza) in combination with abiraterone acetate and prednisone or prednisolone for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), as determined by a diagnostic test approved by the FDA.
JUNE 20: The FDA approves the combination of talazoparib (Talzenna) plus enzalutamide (Xtandi) for the treatment of patients with HRR gene–mutated mCRPC.
JULY 31: The FDA approves dostarlimab (Jemperli) in combination with chemotherapy for the treatment of patients with dMMR/microsatellite instability–high primary advanced or recurrent endometrial cancer.
AUGUST 11: The FDA approves the combination of niraparib and abiraterone acetate (Akeega) tablets with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved diagnostic test.
NOVEMBER 16: Enzalutamide (Xtandi) has been approved for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. With this approval, it becomes the first and only androgen receptor signaling inhibitor that is FDA approved for this population.
JANUARY 19: The FDA grants accelerated approval to tucatinib (Tukysa) in combination with trastuzumab (Herceptin) for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer (mCRC) that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
AUGUST 2: The FDA approves trifluridine/tipiracil (Lonsurf) alone or in combination with bevacizumab (Avastin) for the treatment of adult patients with refractory mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, or if they are RAS wild-type, an anti-EGFR therapy.
NOVEMBER 1: The FDA approves pembrolizumab (Keytruda) plus gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
NOVEMBER 8: The FDA has approved fruquintinib (Fruzaqla; HMPL-013) for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy; and, if disease is RAS wild type and it was deemed medically appropriate, an anti-EGFR therapy.
NOVEMBER 16: The FDA has approved pembrolizumab (Keytruda) and fluoropyrimidine- and platinum-containing chemotherapy for treatment of patients with locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma.
MARCH 16: The FDA approves dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the treatment of pediatric patients 1 year and older with low-grade glioma that harbors a BRAF V600E mutation and who require systemic therapy.
MARCH 22: The FDA grants accelerated approval to retifanlimab-dlwr (Zynyz) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
MARCH 29: The FDA grants full approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, who have progressed after receiving previous treatment and have no satisfactory alternative treatment options.
AUGUST 14: The FDA approves the Hepzato Kit (melphalan/hepatic delivery system). This is a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
OCTOBER 13: The FDA approves nivolumab (Opdivo) as monotherapy for the adjuvant treatment of patients 12 years and older with resected stage IIB or IIC melanoma.
OCTOBER 27: The FDA approves the combination of toripalimab-tpzi (Loqtorzi) with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as a monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.