A Look Back at FDA News from November 2018

In November 2018, the FDA approved several agents for treatment of non—small cell lung cancer (NSCLC), multiple myeloma, peripheral T-cell lymphoma (PTCL), and acute myeloid leukemia (AML) among others. There were also 2 biosimilars approved: pegfilgrastim (Neulasta) and rituximab biosimilarCT-P10 (Truxima; rituximab-abbs).

There were also a number of priority reviews, a fast track designation, and an accelerated approval granted by the FDA during November 2018.

Lorlatinib Granted Approval by FDA for ALK+ NSCLC

Take a look back on the FDA happenings for the month of November 2018:

Pegfilgrastim Biosimilar Approved by FDA

Lorlatinib (Lorbrena) was granted an accelerated approval on November 2, 2018, as a treatment for patients withALK-positive metastatic NSCLC after progressing on 1 or more ALK tyrosine kinases inhibitors.

Brentuximab Vedotin Submitted for FDA Approval in Frontline CD30_ PTCL

On November 5, 2018, the FDA approved egfilgrastim-cbqv (CHS-1701; Udencya), a pegfilgrastim biosimilar for treatment of patients with cancer receiving myelosuppressive chemotherapy. This was also approved by the European Commission in September 2018.

Elotuzumab Triplet Approved by FDA for Treatment of Myeloma

Based on data from the phase III ECHELON-2 trial, brentuximab vedotin (Adcetris) was submitted to the FDA for approval on November 6, 2018. This is indicated for use as a frontline treatment for patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Selinexor Granted Fast Track Designation by FDA for Relapsed/Refractory DLBCL

On November 6, 2018, elotuzumab (Empliciti) received approval from the FDA for combination use with pomalidomide (Pomalyst) and low-dose dexamethasone (EPd) as treatment for patients with relapsed/refractory multiple myeloma who have receive at least 2 prior lines of therapy, including lenolidomide (Revlimid) and a proteasome inhibitor (PI).

Supplemental Application for Avatrombopag in ITP Accepted by FDA

The FDA granted a fast track designation to selinexor for treatment of patients with diffuse large B-cell lymphoma who were previously treated and ineligible to receive high-dose chemotherapy with stem cell rescue or chimeric antigen receptor (CAR) T-cell therapy. This decision, announced on November 7, 2018, was based on data from the phase IIb SADAL trial.

Pembrolizumab Granted Accelerated FDA Approval for HCC

The FDA received a supplemental new drug application (sNDA) for avatrombopag (Doptelet) for treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment. The sNDA was submitted on November 8, 2018, based on data from the phase III Amendment 02 trial.

Olaparib Granted Priority Review by FDA for Frontline Maintenance in Ovarian Cancer

On November 9, 2018, the FDA granted an accelerated approval to pembrolizumab (Keytruda) for treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib (Nexavar).

Atezolizumab Receives Priority Review Designation From FDA for Frontline Treatment of TNBC

On November 12, 2018, the FDA granted priority review to olaparib tablets as a maintenance therapy in patients with newly-diagnosed,BRCA-positive advanced ovarian cancer who have already had a complete or partial response to a prior line of standard frontline platinum-based chemotherapy.

Brentuximab Vedotin Granted FDA Approval for Frontline CD30+ PTCL

Atezolizumab (Tecentriq) received a priority review designation on November 13, 2018, for combination use with nab-paclitaxel in patients with unresectable locally advanced or metastatic PD-L1—positive triple-negative breast cancer. The FDA is scheduled to make a decision by March 12, 2019.

Eltrombopag Approved For Frontline Treatment of Severe Aplastic Anemia

The FDA granted approval of brentuximab vedotin (Adcetris) in combination with chemotherapy for treatment of patients with CD30-expressing PTCL in the frontline setting. This approval, on November 16, 2018, was based on data from the phase III ECHELON-2 trial.

Frontline Venetoclax Granted Accelerated FDA Approval for Older Patients With AML

On November 16, 2018, the FDA approved use of eltrombopag (Promacta) in combination with standard immunosuppressive therapy for treatment of newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia. This indication is an expansion to a previous approved for the eltrombopag combination.

Glasdegib Granted FDA Approval for AML

An accelerated approval has been granted by the FDA for venetoclax (Venclexta) in combination use with azacytidine or decitabine or low-dose cytarabine as a frontline treatment for adult patients with newly-diagnosed AML who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. This decision was announced on November 21, 2018.

FDA Grants Priority Review Designation to Quizartinib for FLT3-ITD+ AML

On November 21, 2018, the FDA granted approval of glasdegib (Daurismo) for combination use with low-dose cytarabine (LDAC) as treatment of patients with newly-diagnosed AML aged 75 year or older, or patients who are ineligible to receive intensive chemotherapy. The decision was based on data from a randomized trial of 111 patients.

Larotrectinib Granted FDA Approval for NTRK+ Cancers

An NDA was granted priority review for quizartinib as a treatment of adult patients with relapsed/refractoryFTL3-ITD—positive AML. The designation, announced on November 26, 2018, was based on data from the phase III QuANTUM-R study.

FDA Approves Rituximab Biosimilar for Treatment of Non-Hodgkin Lymphoma

On November 26, 2018, the FDA granted an accelerated approval to larotrectinib (Vitrakvi) for treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment.

Gilteritinib Granted FDA Approval for Treatment of FLT3+ AML

Rituximab biosimilar, CT-P10, was approved by the FDA on November 28, 2018, for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy. This is the first biosimilar approved for treatment of patients with NHL.