Industry News

FDA Approves Gilteritinib for Acute Myeloid Leukemia

On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

Read the full FDA press release here.

Posted 11/28/2018

FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion
On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

Read the full FDA press release here.

Posted 11/27/2018

FDA Approves Venetoclax for Acute Myeloid Leukemia

On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/18

FDA Approves Glasdegib for Acute Myeloid Leukemia
On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/2018

Imfinzi Assigned Unique HCPCS Code for Reimbursement by CMS

Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab, AstraZeneca) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs:
- J9173: Injection, durvalumab, 10 m
Read the full CY 2019 OPPS Final Rule here.

Posted 11/20/2018

FDA Approves Brentuximab Vedotin for Peripheral T-Cell Lymphoma
On November 16, the U.S. Food and Drug Administration expanded the approved use of brentuximab vedotin (Adcetris, Seattle Genetics) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnoses PTCL, and the agency used a new review program to complete the approval more quickly.

Read the full FDA press release here.

Posted 11/16/2018

FDA Approves Pembrolizumab for Hepatocellular Carcinoma
On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Read the Merck press release here.

Posted 11/12/2018

FDA Approves Elotuzumab, Pomalidomide, Dexamethasone for Multiple Myeloma
On November 6, Bristol-Myers Squibb Company announced that the Food and Drug Administration approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Read the Bristol-Myers Squibb press release here.

Posted 11/7/2018

FDA Approves Lorlatinib for ALK+ Metastatic NSCLC

On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Read the full FDA press release here.

Posted 11/5/2018

FDA Approves Kyprolis Once-Weekly Dosing Option for Multiple Myeloma
On October 1, the FDA approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.

Read the full Amgen press release here.

Posted 10/31/2018

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