FDA Approvals of Brand-Name Prescription Drugs in 2016

2017 Oncology Pharmacy Guide to New FDA Approvals - Annual Novel Pharmaceuticals

The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2016 and are grouped into the following categories:

  1. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
  2. New Indications and New Combinations
  3. New Dosages, Dosage Forms, Formulations, Delivery Systems, and Patient Populations
  4. New Blood Products

I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications

Axumin (NME)
(Fluciclovine F 18; Blue Earth Diagnostics)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: For positron emission tomography imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels after previous treatment
Approval consideration: Priority review
Approval date: May 27, 2016

Defitelio (NME)
(Defibrotide; Jazz Pharmaceuticals)
Class/route: First-in-class anticoagulant; intravenous infusion
Indication: For the treatment of adults and pediatric patients with hepatic veno-occlusive disease with renal or pulmonary dysfunction after hematopoietic stem-cell transplantation
Approval considerations: Fast track, priority review, orphan drug
Approval date: March 30, 2016

Lartruvo (BLA)
(Olaratumab; Eli Lilly)
Class/route: Platelet-derived growth factor receptor- alpha–blocking antibody; intravenous injection
Indication: For the treatment, in combination with doxorubicin, of adults with soft-tissue sarcoma and a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
Approval considerations: Accelerated approval, breakthrough therapy, fast track, priority review, orphan drug
Approval date: October 19, 2016

Netspot (NME)
(Kit for preparation of gallium Ga 68 dotatate injection; Gipharma)
Class/route: Radioactive diagnostic agent; intravenous injection
Indication: For use with positron emission tomography for the localization of somatostatin receptor–positive neuroendocrine tumors in adults and in pediatric patients
Approval considerations: Priority review, orphan drug
Approval date: June 1, 2016

Rubraca (NME)
(Rucaparib; Clovis Oncology)
Class/route: Poly ADP-ribose polymerase inhibitor; oral
Indication: For the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who received ≥2 chemo­therapies; patients should be selected for therapy based on an FDA-approved companion diagnostic for rucaparib
Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug
Approval date: December 19, 2016

Tecentriq (BLA)
(Atezolizumab; Genentech)
Class/route: PD-L1; intravenous infusion
Indications: For the treatment of patients with locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-containing chemotherapy, or with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and for the treatment of patients with metastatic non–small-cell lung cancer whose disease progressed during or after platinum-containing chemotherapy. Patients with EGFR or ALK mutations should have disease progression with FDA-approved therapy for these aberrations before using atezolizumab
Approval considerations: Accelerated approval, breakthrough therapy, priority review
Approval dates: May 18, 2016 (bladder cancer); October 18, 2016 (lung cancer)
Venclexta (NME) (Venetoclax; AbbVie/Genentech)
Class/route: First-in-class BCL-2 inhibitor; oral
Indication: For the treatment of patients with chronic lymphocytic leukemia with 17p deletion (as detected by an FDA-approved test) who have received at least 1 previous therapy
Approval considerations: Accelerated approval, breakthrough therapy, priority review, orphan drug
Approval date: April 11, 2016

BLA indicates biologic license application; NME, new molecular entity; PD-L1, programmed-cell death ligand 1.

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II. New Indications and New Combinations

Afinitor (new indication)
(Everolimus; Novartis)
Class/route: Serine-threonine kinase inhibitor; oral tablets
New Indication: For treatment of adults with progressive neuroendocrine tumors of pancreatic origin and adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced, or metastatic
Existing Indications: For treatment of, in combination with exemestane after nonresponse to treatment with letrozole or anastrozole, postmenopausal women with advanced HR-positive, HER2-negative breast cancer; for adults with advanced renal-cell carcinoma after nonresponse to treatment with sunitinib or sorafenib; for adults with renal angiomyolipoma and tuberous sclerosis complex not requiring immediate surgery

Arzerra (new indications)
(Ofatumumab; Novartis)
Class/route: CD20-directed cytolytic monoclonal antibody; intravenous injection
New Indications: For treatment of relapsed CLL in combination with fludarabine and cyclophosphamide; for extended treatment of recurrent or progressive CLL in patients with complete or partial response after at least 2 lines of therapy
Existing Indications: For treatment of, in combination with chlorambucil, treatment-naïve patients with CLL for whom fludarabine-based therapy is inappropriate; for patients with CLL refractory to fludarabine and to alemtuzumab

Avastin (new indications)
(Bevacizumab; Genentech)
Class/route: VEGF inhibitor; intravenous infusion
New Indications: For treatment, in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and for recurrent epithelial ovarian, fallopian, or primary peritoneal cancer that is platinum-sensitive, in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab as a single agent
Existing Indications: For treatment, in combination with paclitaxel, with pegylated liposomal doxorubicin, or with topotecan, of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with chemotherapy, for treatment of patients with metastatic colorectal cancer; nonsquamous NSCLC; glioblastoma; metastatic renal-cell carcinoma; or cervical cancer
Approval consideration: Priority review

Blincyto (new indication)
(Blinatumomab; Amgen)
Class/route: Bispecific CD19-directed CD3 T-cell engager; intravenous injection
New Indication: For treatment of pediatric patients with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Existing Indication: For treatment of adults with Ph- negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Approval considerations: Accelerated approval, REMS program

Darzalex (new indication)
(Daratumumab; Janssen Biotech)
Class/route: CD38-directed cytolytic antibody; intravenous injection
New Indication: For treatment, in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, of patients with multiple myeloma who have received at least 1 previous therapy
Existing Indications: For use as monotherapy in patients with multiple myeloma who have received at least 3 previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or those who are double refractory to a proteasome inhibitor and an immunomodulatory agent
Approval consideration: Breakthrough therapy

Gazyva (new indication)
(Obinutuzumab; Genentech)
Class/route: CD20-directed cytolytic antibody; intravenous injection
New Indication: For treatment of, in combination with bendamustine followed by obinutuzumab monotherapy, patients with follicular lymphoma whose disease relapsed after, or who are refractory to, a rituximab­containing regimen
Existing Indication: For treatment, in combination with chlorambucil, of patients with previously untreated CLL
Approval consideration: Priority review
Gilotrif (new indication) (Afatinib; Boehringer Ingelheim)
Class/route: TKI; oral tablets
New Indication: For treatment of patients with metastatic squamous NSCLC that has progressed after platinum-­based chemotherapy
Existing Indication: For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test

Halaven (new indication)
(Eribulin mesylate; Eisai)
Class/route: Microtubule inhibitor; intravenous injection
New Indication: For treatment of unresectable or metastatic liposarcoma in patients who have received an
anthracycline-containing regimen
Existing Indication: For treatment of metastatic breast cancer in patients who have received ≥2 chemotherapeutic regimens, including an anthracycline and a taxane in the adjuvant or metastatic setting
Approval considerations: Orphan drug, priority review

Ibrance (new indication)
(Palbociclib; Pfizer)
Class/route: CDK4 and CDK6 inhibitor; oral capsules
New Indication: For treatment, in combination with fulvestrant, of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression after endocrine therapy
Existing Indication: For treatment of, in combination with letrozole as initial endocrine-based therapy in postmenopausal women, with HR-positive, HER2- negative advanced or metastatic breast cancer
Approval considerations: Accelerated approval, breakthrough therapy, priority review

Imbruvica (new indications)
(Ibrutinib; Pharmacyclics, Janssen Biotech)
Class/route: Bruton’s TKI; oral capsules
New Indications: For treatment of patients with CLL or SLL; for treatment of CLL or SLL in patients with 17p deletion (January 19, 2017: first nonchemotherapy approved for relapsed or refractory marginal zone lymphoma in patients requiring systemic therapy who had received at least 1 anti-CD20–based therapy)
Existing Indications: For treatment of mantle-cell lymphoma in patients who have received at least 1 previous therapy; for treatment of Waldenström’s macroglobulinemia
Keytruda (new indications) (Pembrolizumab; Merck)
Class/route: PD-1–blocking antibody; intravenous injection
New Indications: For treatment of metastatic NSCLC in patients whose tumors have high PD-L1 expression, as determined by an FDA-approved test, and no EGFR or ALK mutations and no previous systemic chemotherapy treatment; for treatment of metastatic NSCLC in patients whose tumors express PD-L1, as determined by an FDA-approved test, and disease progression during or after platinum-containing chemotherapy; for treatment of recurrent or metastatic head and neck squamous-cell carcinoma in patients with disease progression during or after platinum-containing chemotherapy
Existing Indications: Unresectable or metastatic melanoma
Approval consideration: Accelerated approval

Kyprolis (new indication)
(Carfilzomib; Amgen)
Class/route: Proteasome inhibitor; intravenous injection
New Indication: For treatment of, in combination with dexamethasone or with lenalidomide plus dexamethasone, patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy
Existing Indication: As monotherapy for treatment of relapsed or refractory multiple myeloma in patients who have received ≥1 lines of therapy

Lenvima (new indication)
(Lenvatinib; Eisai)
Class/route: Receptor TKI; oral capsules
New Indication: For treatment, in combination with everolimus, of patients with advanced renal-cell carcinoma after 1 previous antiangiogenic therapy
Existing Indication: For treatment, as monotherapy, of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
Approval considerations: Priority review, breakthrough therapy
Opdivo (new indications) (Nivolumab; Bristol-Myers Squibb)
Class/route: PD-1–blocking antibody; intravenous injection
New Indications: For treatment, in combination with ipilimumab, of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic melanoma; classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem-cell transplantation and posttransplant brentuximab vedotin; for treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck, with disease progression during or after platinum-­based therapy
Existing Indications: For treatment of metastatic melanoma; metastatic NSCLC; renal-cell carcinoma
Approval consideration: Accelerated approval
See also New Dosage listing

Tarceva See New Patient Population listing

Tecentriq See NMEs and New BLAs listing

Troxyca ER (new combination)
(Oxycodone hydrochloride and naltrexone hydro­chloride; Pfizer)
Classes/route: Opioid agonist and opioid antagonist; extended-release, abuse-deterrent oral capsules, CII
Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Approval consideration: REMS program

Xalkori (new indication)
(Crizotinib; Pfizer)
Class/route: Receptor TKI; oral capsules
New Indication: For treatment of metastatic NSCLC in patients with ROS1 mutation
Existing Indication: For treatment of metastatic NSCLC in patients with ALK mutation, as detected by an FDA-approved test

ALK indicates anaplastic lymphoma kinase; BLA, biologic license application; CDK, cyclin-dependent kinase; CLL, chronic lymphocytic leukemia; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; NME, new molecular entity; NSCLC, non–small-cell lung cancer; PD, programmed-cell death; PD-L1, PD ligand 1; Ph, Philadelphia chromosome; REMS, Risk Evaluation and Mitigation Strategy; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

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III. New Dosages, New Dosage Forms, New Formulations, New Delivery Systems, and New Patient Populations

Ameluz (new dosage form)
(A minolevulinic acid hydrochloride; Biofrontera AG)
Class/route: Porphyrin precursor; topical gel
New dosage form: 10% gel
Existing dosage form: 20% solution for topical use
Indication: For the lesion-directed and field-directed treatment, in combination with photodynamic therapy using BF-RhodoLED lamp, of mild-to-moderate actinic keratoses on the face and scalp

Cabometyx (new dosage form)
(Cabozantinib; Exelixis)
Class/route: Kinase inhibitor; oral tablets
New dosage form: 20-mg, 40-mg, and 60-mg tablets
Existing dosage form: Oral capsules
Indication: For treatment of advanced renal-cell carcinoma in patients who received previous anti­angiogenic therapy

Evomela (new formulation)
(Melphalan; Spectrum Pharmaceuticals)
Class/route: Bischloroethylamine alkylating agent; intravenous infusion
New formulation: Melphalan that is free of propylene glycol, with Captisol technology to improve the solubility and stability of melphalan
Existing formulation: Melphalan with propylene glycol as a cosolvent
Indications: For high-dose conditioning treatment before hematopoietic progenitor-cell transplantation in patients with multiple myeloma; for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate

Opdivo (new dosage)
(Nivolumab; Bristol-Myers Squibb)
Class/route: PD-1–blocking antibody; intravenous
New dosage: 240 mg intravenously every 2 weeks until disease progression or intolerable toxicity
Existing dosage: Single-dose regimen of 3 mg/kg intra­venously every 2 weeks
Indications: For unresectable or metastatic melanoma; metastatic NSCLC; advanced renal-cell carcinoma; Hodgkin lymphoma
See also New Indications listing

Sustol extended-release (new formulation)
(Granisetron; Heron Therapeutics)
Class/route: Serotonin-3 receptor antagonist; subcutaneous injection
New formulation: Extended-release injection using a polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days
Indication: For use in adults, in combination with other antiemetics, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens

Syndros (new dosage form)
(Dronabinol; Insys Therapeutics)
Class/route: Cannabinoid; oral solution
New dosage form: 5-mg/mL oral solution
Existing dosage form: 2.5-mg, 5-mg, 10-mg capsules
Indications: For treatment of anorexia associated with weight loss in patients with AIDS; for treatment of chemotherapy-induced nausea and vomiting in patients with cancer who had not responded adequately to conventional antiemetic treatments

Tarceva (new patient population)
(Erlotinib; OSI Pharmaceuticals)
Class/route: TKI; oral tablets
New patient population: Patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, that is progressing after at least 1 previous chemotherapy regimen
Existing patient population: Patients with locally advanced, unresectable, or metastatic pancreatic cancer
Indications: For treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 substitution mutations; for first-line treatment, in combination with gemcitabine, of locally advanced, unresectable or metastatic pancreatic cancer
Xtampza ER (new formulation)
(Oxycodone; Collegium Pharmaceutical)
Class/route: Opioid agonist; oral capsules
New formulation: Abuse-deterrent, extended-release, twice-daily oral capsules
Indication: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
Approval consideration: REMS program

EGFR indicates epidermal growth factor receptor; NSCLC, non–small-cell lung cancer; PD-1, programmed-cell death 1; REMS, Risk Evaluation and Mitigation Strategy; TKI, tyrosine kinase inhibitor.

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IV. New Blood Products

Afstyla (new blood product)
(Antihemophilic factor [recombinant], single chain; CSL Behring)
Class/route: Recombinant, antihemophilic factor; intravenous infusion
Indications: For treatment of patients with hemophilia A for on-demand treatment and controlling of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding

Cuvitru (new blood product)
(Immune globulin subcutaneous; Baxalta US)
Class/route: Immune globulin subcutaneous (human); subcutaneous infusion
Indication: As replacement therapy for primary humoral immunodeficiency in adult and pediatric patients aged ≥2 years
Idelvion (new blood product)
(Coagulation factor IX, albumin fusion protein; CSL Behring)
Class/route: Recombinant blood coagulation factor IX; intravenous infusion
Indications: For children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Kovaltry (new blood product)
(Antihemophilic factor; Bayer HealthCare)
Class/route: Recombinant antihemophilic factor VIII concentrate; intravenous infusion
Indications: For children and adults with hemophilia A (congenital factor VIII deficiency) for on-demand
treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes

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Related Items
FDA Approvals of Brand-Name Prescription Drugs in 2015
2016 Oncology Pharmacy Guide to New FDA Approvals published on May 12, 2016 in Annual Novel Pharmaceuticals
Last modified: May 4, 2017