RJ Health Monthly Specialty FDA Actions Newsletter – June 2018 – Volume 1 – Number 6

There were a total of three new FDA drug approvals in June that we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned six new products for review.


Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.


 

New Specialty Drug Approvals – New FDA drug approvals in June

 

Drug Name

Manufacturer

Route of Administration

Indication

Approval Date

FULPHILA™ (pegfilgrastim-jmdb) – Biosimilar to Neulasta®

Mylan

subcutaneous Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs

June 4, 2018

BRAFTOVI™ (encorafenib)

Array Biopharma

Oral Use in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

June 27, 2018

MEKTOVI® (binimetinib)

Array Biopharma

Oral Use in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

June 27, 2018


New Specialty Supplemental Indication Updates – Approved updated supplemental indications on currently marketed drugs in the previous month

 

Drug Name Manufacturer Route of Administration Indication Approval Date
Alimta®

(pemetrexed)

Lilly Intravenous In combination with pembrolizumab and carboplatin, for the first-line treatment of metastatic, non-squamous, non-small cell lung cancer June 4, 2018
RITUXAN® (rituximab) Genentech Intravenous Moderate to severe Pemphigus Vulgaris (PV) in adult patients June 7, 2018
KEYTRUDA® (pembrolizumab) Merck Intravenous Treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy June 13, 2018
KEYTRUDA® (pembrolizumab) Merck Intravenous Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status June 19, 2018
AVASTIN® (bevacizumab) Genentech Intravenous Use in combination with carboplatin and paclitaxel, followed by Avastin as single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. June 13, 2018
TECENTRIQ® (atezolizumab) Genentech Intravenous Treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherapy, and whose tumors express PDL1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), or are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression. June 19, 2018

 


Specialty Drug FDA Actions – New and supplemental FDA filings in June

 

Drug Name Manufacturer Type of Application Indication Route PDUFA Date
Hemlibra (emicizumab-kxwh) Roche sBLA Adults and children with haemophilia A without factor VIII inhibitors Subcutaneous October 4, 2018
talazoparib Pfizer NDA Treatment of patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC) Oral December 2018
Trastuzumab
(resubmission of application)
Celltrion aBLA Treat cancer patients whose tumors have either HER2 overexpression or HER2 gene Intravenous Q4 2018
Keytruda
(pembrolizumab)
Merck sBLA Adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma Intravenous February 16, 2019
IMBRUVICA (ibrutinib) AbbVie sNDA In combination with rituximab (RITUXAN) as a new treatment option for Waldenström’s macroglobulinemia Oral No Date Available
glasdegib Pfizer NDA Treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine Oral December 27, 2018

Looking Ahead – Anticipated FDA actions for specialty drugs in 2018

 

Drug Name Manufacturer Indication Route PDUFA Date
Xtandi

(enzalutamide)

Astellas Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer Oral 7/2/2018
Keytruda
(pembrolizumab)
Merck Primary Mediastinal B-Cell Lymphoma Intravenous 7/3/2018
Opdivo + Yervoy
(ipilimumab + nivolumab)
Bristol-Myers Squibb Colorectal Cancer Intravenous 7/10/2018
filgrastim Adello Biologics Febrile Neutropenia Intravenous; Subcutaneous 7/11/2018
Rituxan

(rituximab)

Genentech Pemphigus Vulgaris Intravenous 7/13/2018
Kymriah
(tisagenlecleucel)
Novartis Diffuse Large B-Cell Lymphoma Intravenous 7/17/2018
Azedra
(iobenguane I 131)
Progenics Pharmaceuticals Paraganglioma (Glomus Jugulare Tumor); Pheochromocytoma Intravenous 7/30/2018
Lorlatinib Pfizer Non-Small Cell Lung Cancer Oral 8/10/2018
patisiran Alnylam Pharmaceuticals Familial Amyloid Neuropathies Oral 8/11/2018
migalastat hydrochloride Amicus Therapeutics Fabry Disease Oral 8/13/2018
Opdivo
(nivolumab)
Bristol-Myers Squibb Small-Cell Lung Cancer Intravenous 8/16/2018
Ivosidenib Agios Pharmaceuticals Refractory Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia Oral 8/21/2018
Lenvima
(lenvatinib mesylate)
Eisai Hepatocellular Carcinoma Oral 8/24/2018
lusutrombopag Shionogi Thrombocytopenia Oral 8/26/2018
lanadelumab Shire Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) Subcutaneous 8/26/2018
volanesorsen sodium Akcea Therapeutics Familial Chylomicronemia (Type I Hyperlipoproteinemia) Intravenous 8/30/2018
moxetumomab pasudotox MedImmune Hairy Cell Leukemia Intravenous 9/3/2018
mogamulizumab Kyowa Hakko Kirin Cutaneous T-Cell Lymphoma Intravenous 9/4/2018
Tecentriq
(atezolizumab)
F. Hoffmann-La Roche Non-Small Cell Lung Cancer Intravenous 9/5/2018
Fremanezumab Teva Migraine Subcutaneous 9/16/2018
Ruconest
(C1 esterase inhibitor (recombinant))
Pharming Group Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) Intravenous 9/21/2018
dacomitinib) Pfizer Non-Small Cell Lung Cancer Oral 9/30/2018
duvelisib Verastem Follicular Lymphoma; Refractory Chronic Lymphocytic Leukemia (CLL); Relapsed Chronic Lymphocytic Leukemia (CLL) Oral 10/5/2018
inotersen sodium Ionis Pharmaceuticals Familial Amyloid Neuropathies Subcutaneous 10/6/2018
Dupixent
(dupilumab)
Regeneron Pharmaceuticals Asthma Subcutaneous 10/20/2018
cemiplimab Regeneron Pharmaceuticals Squamous Cell Carcinoma Intravenous 10/28/2018
pegfilgrastim Coherus BioSciences Febrile Neutropenia Subcutaneous 11/3/2018
adalimumab biosimilar Sandoz Ankylosing Spondylitis (Bekhterev’s Disease); Anterior Uveitis; Axial Spondyloarthritis; Crohn’s Disease (Regional Enteritis); Hidradenitis Suppurativa; Intermediate Uveitis; Plaque Psoriasis (Psoriasis Vulgaris); Polyarticular Juvenile Idiopathic Arthritis (PJIA); Posterior Uveitis; Psoriatic Arthritis; Rheumatoid Arthritis; Ulcerative Colitis Subcutaneous 11/16/2018
emapalumab NovImmune Hemophagocytic Lymphohistiocytosis Intravenous 11/20/2018
larotrectinib Loxo Oncology Solid Tumor Oral 11/26/2018
gilteritinib fumarate Astellas Refractory Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia Oral 11/29/2018
Promacta
(eltrombopag olamine)
Novartis Aplastic Anemia Oral 11/30/2018
 incobotulinumtoxin A Merz Sialorrhoea Intramuscular 12/1/2018
talazoparib Pfizer Metastatic Breast Cancer Oral 12/7/2018
Oncaspar
(calaspargase pegol)
Shire Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) Intravenous 12/22/2018
 glasdegib Pfizer Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) Oral 12/27/2018

Terms & Abbreviations:

  1. aNDA: Abbreviated New Drug Application
  2. BLA: Biologics License Application
  3. FDA: Food and Drug Administration
  4. NDA: New Drug Application
  5. sBLA: supplemental Biologics License Application
  6. sNDA: supplemental New Drug Application
  7. PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process
  8. PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months
  9. sBLA: supplemental Biologics License Application
  10. sNDA: supplemental New Drug Application

References:

U.S. Food and Drug Administration. Center for Drug Evaluation and Research Advancing Health Through Innovation 2017 New Drug Therapy Approvals. Downloaded June 29, 2018. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf?utm_campaign=Advancing%20Health%20through%20Innovation%3A%20New%20Drug%20Approvals%20and%20Other%20Drug%20Therapy%20Advances%20of%202017&utm_medium=email&utm_source=Eloqua

Pharma Intelligence Center Web Site. Accessed June 29, 2018. https://pharma.globaldata.com

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Accessed June 29, 2018.  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

U.S. Food and Drug Administration. Novel Drug Approvals for 2017. Accessed June 29, 2018.  https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm

 

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