FDA Oncology Announcements

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74 Announcements

2026-03-20

FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, doxorubicin · Anthracycline
Condition: Lymphoid

2026-02-19

FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trial: AMPLIFY
Drugs: Calquence (acalabrutinib) · BTK inhibitor, Venclexta (venetoclax) · Bcl-2 inhibitor
Conditions: LymphoidOther hematologic neoplasm

2025-12-04

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

Trial: TRANSCEND FL
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2025-12-03

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Trial: BRUIN CLL-321
Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

2025-11-18

FDA approves epcoritamab-bysp for follicular lymphoma indications

Trial: EPCORE FL-1
Drugs: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

2025-06-18

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

Trial: InMIND
Drugs: Monjuvi (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

2025-02-12

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

Trial: ECHELON-3
Drugs: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

2025-01-16

FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma

Drugs: Calquence (acalabrutinib) · BTK inhibitor, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

2024-11-15

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

Drug: Revuforj (revumenib) · KMT2A inhibitor
Conditions: LymphoidMyeloidOther hematologic neoplasm

2024-11-08

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Drug: Aucatzyl (obecabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

2024-06-26

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

Trial: EPCORE™ NHL-1
Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

2024-06-14

FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

Drug: Blincyto (blinatumomab) · Anti-CD19-CD3 bispecific antibody
Conditions: LymphoidOther hematologic neoplasm

2024-05-30

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2024-05-15

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2024-03-19

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

Drug: Iclusig (ponatinib) · Bcr-Abl inhibitor
Conditions: LymphoidOther hematologic neoplasm

2024-03-07

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

Trial: ROSEWOOD
Drugs: Brukinsa (zanubrutinib) · BTK inhibitor, obinutuzumab · Anti-CD20 antibody
Condition: Lymphoid

2024-03-06

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

Drug: Besponsa (inotuzumab ozogamicin) · Anti-CD22 antibody-drug conjugate
Conditions: LymphoidOther hematologic neoplasm

2023-12-01

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

2023-06-16

FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas

Drug: Columvi (glofitamab-gxbm) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

2023-05-19

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

2023-04-19

FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

Trial: POLARIX
Drugs: Polivy (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, rituximab · Anti-CD20 antibody
Condition: Lymphoid

2023-01-27

FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma

Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Condition: Lymphoid

2023-01-19

FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trials: SEQUOIA, ALPINE
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

2022-12-23

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

Drug: Lunsumio (mosunetuzumab-axgb) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

2022-11-10

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

Drugs: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate, doxorubicin · Anthracycline
Condition: Lymphoid

2022-08-26

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Drug: Pemazyre (pemigatinib) · FGFR inhibitor
Conditions: LymphoidMyeloid

2022-06-24

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Trial: TRANSFORM
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2022-05-27

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

Trial: ELARA
Drug: Kymriah (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2022-04-01

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2021-10-01

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Trial: ZUMA-3
Drug: Tecartus (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

2021-09-14

FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma

Trial: MAGNOLIA
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

2021-08-31

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

Trial: ASPEN
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

2021-07-01

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

Drug: Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) · Asparagine-specific enzyme
Conditions: LymphoidOther hematologic neoplasm

2021-04-23

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

Trial: LOTIS-2
Drug: Zynlonta (loncastuximab tesirine-lpyl) · Anti-CD19 antibody-drug conjugate
Condition: Lymphoid

2021-03-05

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

Trial: ZUMA-5
Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2021-02-05

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma

Trial: UNITY-NHL
Drug: Ukoniq (umbralisib) · PI3K delta inhibitor
Condition: Lymphoid

2021-02-05

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2021-01-14

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

Drug: Xalkori (crizotinib) · ALK inhibitor
Condition: Lymphoid

2020-10-14

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

Trial: MK-3475-204
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Lymphoid

2020-07-31

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial: L-MIND
Drugs: MONJUVI (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

2020-07-24

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma

Trial: ZUMA-2
Drug: TECARTUS (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

2020-06-22

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

Drug: XPOVIO (selinexor) · XPO1 inhibitor
Condition: Lymphoid

2020-06-18

FDA granted accelerated approval to tazemetostat for follicular lymphoma

Drug: TAZVERIK (tazemetostat) · EZH inhibitor
Condition: Lymphoid

2020-04-21

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs: IMBRUVICA (ibrutinib) · BTK inhibitor, rituximab · Anti-CD20 antibody
Conditions: LymphoidOther hematologic neoplasm

2019-11-21

Project Orbis: FDA approves acalabrutinib for CLL and SLL

Trial: ElevateTN
Drug: CALQUENCE (acalabrutinib) · BTK inhibitor
Condition: Lymphoid

2019-11-14

FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma

Drug: BRUKINSA (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

2019-06-10

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma

Drugs: POLIVY (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

2019-05-28

FDA approves lenalidomide for follicular and marginal zone lymphoma

Trials: AUGMENT, MAGNIFY
Drugs: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

2019-05-15