FDA Oncology Announcements

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115 Announcements

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

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

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

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

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

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

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

FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

Condition: Lymphoid

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

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

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

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

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

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

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

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

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

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

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

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

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

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

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

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

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

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

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

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

FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma

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

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

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

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)

Drug: Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) · Asparagine-specific enzyme
Condition: Lymphoid

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

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

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

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

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

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

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

Trial: ZUMA-7
Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

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

FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma

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

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

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

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

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

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

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

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

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

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

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

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

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

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

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

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

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

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

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

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

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

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

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

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

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

FDA granted accelerated approval to tazemetostat for follicular lymphoma

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

FDA granted accelerated approval to tazemetostat for follicular lymphoma

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

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

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

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

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

Project Orbis: FDA approves acalabrutinib for CLL and SLL

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

FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma

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

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

FDA approves lenalidomide for follicular and marginal zone lymphoma

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

FDA approves venetoclax for CLL and SLL

Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves longer-acting calaspargase pegol-mknl for ALL

Drug: ASPARLAS (calaspargase pegol-mknl) · Asparagine-specific enzyme
Condition: Lymphoid

FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma

Drugs: Truxima (rituximab-abbs) · Anti-CD20 antibody, Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Trial: MURANO
Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

Trial: ECHELON-2
Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Trial: DYNAMO + R
Drug: COPIKTRA (duvelisib) · PI3K delta inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia

Drug: LUMOXITI (moxetumomab pasudotox-tdfk) · Anti-CD22 immunotoxin
Conditions: LymphoidOther hematologic neoplasm

FDA approves mogamulizumab-kpkc for mycosis fungoides or Sézary syndrome

Drug: Poteligeo (mogamulizumab-kpkc) · Anti-CCR4 antibody
Condition: Lymphoid

FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

Trial: MK-3475-170
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Lymphoid

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma

Trial: JULIET
Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

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

Brentuximab Vedotin

Drug: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

FDA approves obinutuzumab for previously untreated follicular lymphoma

Drug: GAZYVA (obinutuzumab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma

Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

FDA grants accelerated approval to acalabrutinib for mantle cell lymphoma

Drug: Calquence (acalabrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves axicabtagene ciloleucel for large B-cell lymphoma

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

FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma

Drug: ALIQOPA (copanlisib) · PI3K delta inhibitor
Condition: Lymphoid

FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome

Trial: ELIANA
Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

Drug: BESPONSA (inotuzumab ozogamicin) · Anti-CD22 antibody-drug conjugate
Condition: Lymphoid

FDA grants regular approval to blinatumomab and expands indication to include Philadelphia chromosome-positive B cell

Drug: BLINCYTO (blinatumomab) · Anti-CD19-CD3 bispecific antibody
Condition: Lymphoid

FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL

Drug: RITUXAN HYCELA (rituximab and hyaluronidase human) · Anti-CD20 antibody
Condition: Lymphoid

Nivolumab (Opdivo) for Hodgkin Lymphoma

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Lymphoid

Venetoclax (Venclexta) Tablets

Drug: VENCLEXTA tablets (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

Obinutuzumab

Drugs: Gazyva (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Ofatumumab (Arzerra Injection)

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody
Condition: Lymphoid

Brentuximab Vedotin Approved for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression

Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

Ibrutinib (Imbruvica)

Drug: Imbruvica Capsules (ibrutinib) · BTK inhibitor
Condition: Lymphoid

Blinatumomab

Drug: BLINCYTO (blinatumomab) · Anti-CD19-CD3 bispecific antibody
Condition: Lymphoid

Idelalisib

Drugs: Zydelig tablets (idelalisib) · PI3K delta inhibitor, rituximab · Anti-CD20 antibody
Condition: Lymphoid

Belinostat

Drug: BELEODAQ (belinostat) · HDAC inhibitor
Condition: Lymphoid

Mercaptopurine

Drug: Purixan (mercaptopurine) · Purine analog
Condition: Lymphoid

Siltuximab

Drug: Sylvant Injection Janssen Biotech (siltuximab) · Anti-IL-6 antibody
Condition: Lymphoid

FDA Approves Ofatumumab

Drugs: Arzerra (ofatumumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Ibrutinib (IMBRUVICA)

Drug: IMBRUVICA (ibrutinib) · BTK inhibitor
Condition: Lymphoid

FDA grants accelerated approval to Ibrutinib (Imbruvica)

Drug: IMBRUVICA (Ibrutinib) · BTK inhibitor
Condition: Lymphoid

Gazyva (obinutuzumab)

Drugs: GAZYVA (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Inclusig (ponatinib)

Conditions: LymphoidMyeloid

FDA Approves Lenalidomide

Drug: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

FDA Approves Ponatinib

Drug: Iclusig tablets (ponatinib) · Bcr-Abl inhibitor
Conditions: LymphoidMyeloid

Rituximab Infusion

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

vinCRIStine sulfate LIPOSOME injection

Drug: Marqibo (vinCRIStine sulfate LIPOSOME) · Vinca alkaloid
Condition: Lymphoid

asparaginase Erwinia chrysanthemi

Drug: Erwinaze (asparaginase erwinia chrysanthemi) · Asparagine-specific enzyme
Condition: Lymphoid

Brentuximab Vedotin

Drug: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

Rituximab 2011

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

Rituximab

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

Romidepsin

Drugs: ISTODAX (romidepsin) · HDAC inhibitor, ISTODAX (injection)
Condition: Lymphoid

Ofatumumab

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody
Condition: Lymphoid

Pralatrexate Injection (Folotyn)

Drug: FOLOTYN (pralatrexate) · Antifolate
Condition: Lymphoid

Plerixafor

Drug: Mozobil (plerixafor) · CXCR4 inhibitor
Conditions: LymphoidPlasma cell

Bendamustine Hydrochloride

Drug: TREANDA (bendamustine hydrochloride) · Nitrogen mustard
Condition: Lymphoid

Denileukin Diftitox

Drug: Ontak (denileukin diftitox) · Anti-IL-2R immunotoxin
Condition: Lymphoid

Bendamustine Hydochloride

Drug: Treanda (bendamustine hydrochloride) · Nitrogen mustard
Conditions: Classical hematologyLymphoid

FDA Approves Dasatinib

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Conditions: LymphoidMyeloid

FDA approves bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy

Drug: VELCADE (bortezomib) · Proteasome inhibitor
Condition: Lymphoid

FDA approves vorinostat (Zolinza) for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL)

Drug: Zolinza (vorinostat) · HDAC inhibitor
Condition: Lymphoid

FDA approves two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA Approves pegaspargase (Oncaspar, Enzon Pharmaceuticals, Inc) for the first-line treatment of patients with acute lymphoblastic leukemia

Drug: Oncaspar (pegaspargase) · Asparagine-specific enzyme
Conditions: LymphoidOther hematologic neoplasm

Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events

Condition: Lymphoid

FDA approves rituximab (Rituxan) for use in the first‑line treatment of patients with diffuse large B-cell, CD20‑positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline‑based chemotherapy regimens

Drugs: Rituxan (rituximab) · Anti-CD20 antibody, cyclophosphamide · Nitrogen mustard
Condition: Lymphoid