FDA Oncology Announcements

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18 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 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 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 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 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 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 approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspension

Drug: Imbruvica (ibrutinib) · BTK inhibitor
Condition: Other

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 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 grants accelerated approval to acalabrutinib for mantle cell lymphoma

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

FDA expands ibrutinib indications to chronic GVHD

Drug: Imbruvica (ibrutinib) · BTK inhibitor
Condition: Other

Ibrutinib (Imbruvica)

Drug: Imbruvica Capsules (ibrutinib) · BTK inhibitor

Ibrutinib (IMBRUVICA)

Drug: IMBRUVICA (ibrutinib) · BTK inhibitor

FDA grants accelerated approval to Ibrutinib (Imbruvica)

Drug: IMBRUVICA (Ibrutinib) · BTK inhibitor