Lymphoma Treatment Approval Timeline

The following is a timeline of FDA approvals for different lymphoma indications and Breakthrough Therapy Designation’s for recently developed targeted therapies:

September 2017 – Copanlisib was granted accelerated approval for treatment of patients with relapsed follicular lymphoma (FL) who have received at least two prior lines of therapy.

June 2017 ­ Subcutaneous administration of rituximab hyaluronidase was approved to treat patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL) who have previously received one line of intravenous (IV) rituximab.

January 2017 – Ibrutinib was approved to treat patients with marginal zone lymphoma (MZL), a type of non-Hodgkin lymphoma, who have received at least one line of prior therapy.

August 2016 – Ofatumumab received FDA approval for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.

May 2016 – Nivolumab received accelerated  FDA approval for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin.

April 2016 – Pembrolizumab received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma.

April 2016 – Venetoclax received FDA approval for the treatment of patients with chronic lymphocytic leukemia (CLL) with the 17p deletion genetic mutation and who have been treated with at least one prior therapy.

March 2016 – Ibrutinib received FDA approval for first-line use in patients with chronic lymphocytic leukemia (CLL).

February 2016 – Obinutuzumab received FDA approval in combination with bendamustine followed by obinutuzumab montherapy for the treatment of patients with follicular lymphoma who relapsed after treatment, or are refractory to rituximab.

January 2016 – Venetoclax received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, for use in combination with rituximab (Rituxan) to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

January 2016Ofatumumab received FDA approval for use in patients with recurrent or progressive chronic lymphocytic leukemia (CLL) who are in complete or partial response following at least two prior treatment therapies.

May 2015 – Venetoclax received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, for use in relapsed or refractory chronic lymphocytic leukemia (CLL) in previously treated patients with the 17p deletion genetic mutation.

January 2015 – Ibrutinib received FDA approval for use as a monotherapy in patients with Waldenstrom’s macroglobulinemia (WM).

October 2014 – Bortezomib received FDA approval for use in previously untreated mantle cell lymphoma (MCL).

July 2014 – Ibrutinib received FDA approval for expanded use in chronic lymphocytic leukemia (CLL) patients with 17p deletion.

July 2014 – Idelalisib received FDA approval for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

July 2014 – Idelalisib received accelerated  FDA approval for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL).

July 2014  Idelalisib received accelerated FDA approval for the treatment of relapsed small lymphocytic lymphoma (SLL).

July 2014 – Belinostat received accelerated FDA approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

May 2014 – Nivolumab received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, in the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and Brentuximab vedotin.

April 2014 – Ofatumumab received FDA approval in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

February 2014 – Ibrutinib received accelerated FDA approval for the treatment of patients with chronic lymphocytic leukemia (CLL) and at least one prior treatment.

November 2013 – Ibrutinib received accelerated FDA approval for the treatment of patients with mantle cell lymphoma (MCL), who have received at least one prior therapy.

November 2013 – Obinutuzumab received FDA approval in combination with chlorambucil for the treatment of patients, who have not previously received treatment for their chronic lymphocytic leukemia (CLL).

September 2013 – Idelalisib received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL).

September 2013 – Ofatumumab received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL) in patients who are ineligible for fludarabine-based therapy.

June 2013 – Lenalidomide received FDA approval for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

May 2013 – Obinutuzumab received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, in combination with chemotherapy for the treatment of patients, who have not previously received treatment for their chronic lymphocytic leukemia (CLL).

April 2013 – Ibrutinib received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (deletion 17p).

February 2013 – Ibrutinib received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, as a monotherapy for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

February 2013 – Ibrutinib received the FDA Breakthrough Therapy Designation, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy, as a monotherapy for the treatment of patients with Waldenstrom’s macroglobulinemia (WM).

August 2011 – Brentuximab received FDA approval for use in 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.

August 2011 – Brentuximab received accelerated FDA approval for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT), or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

August 2011– Brentuximab received FDA approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

October 2009 – Ofatumumab received accelerated FDA approval for treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine.

October 2008 – Bendamustine received FDA approval for indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

March 2008 – Bendamustine received FDA approval for injection, for intravenous infusion, for the treatment of patients with chronic lymphocytic leukemia (CLL).

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