Specialty Drugs Year in Review Part II: Oncology Drugs and Late-breaking FDA Actions

Last year was another year in which specialty pharmaceuticals featured prominently in the FDA’s new drug approval and expanded indications list.

Below is the second installment of a summary of specialty pharmacy-related FDA approvals and expanded indications that took place in 2016. The first installment reviewed non-oncology specialty actions in 2016, while this installment reviews approvals related to oncology drugs, as well as late-breaking FDA actions that took place after the first installment was published.

Consult the respective product-prescribing monographs for complete information, including dosing regimens. New oncology molecular entities that were approved in 2016 are detailed below, and previously approved oncology drugs that received expanded indications in 2016 are listed below in Chart 1.

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Leukemias and Lymphomas

On April 11, 2016, Venclexta (venetoclax) was approved by the FDA for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test (companion diagnostic Vysis CLL FISH probe kit), who received at least 1 prior therapy. Venclexta is a BCL-2 inhibitor that was granted breakthrough therapy designation, priority review, and accelerated approval based on overall response rate.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The recommended dosage of Venclexta is initially 20-mg once daily for 7 days, followed by a weekly ramp-up dosing schedule to the recommended daily dose of 400-mg.

Venclexta tablets should be taken orally, once daily with a meal and water. It is recommended to assess patient-specific factors for level of risk of tumor lysis syndrome (TLS), and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of Venclexta to reduce the risk of TLS. Venclexta comes in a 10-mg, 50-mg, and 100-mg tablet for oral use. Venclexta has a starter pack that provides the first 4 weeks of medication according to the ramp-up schedule.^1,2

Multiple Myeloma

On March 10, 2016, Evomela (melphalan) was approved for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

Evomela is an alkylating drug that is available in a 50-mg single dose vial, as a lyophilized powder for reconstitution. The recommended dosage for Evomela for conditioning treatment is 100-mg/m2 per day administered over 30 minutes by intravenous infusion for 2 consecutive days (day -3 and day -2) prior to autologous stem cell transplantation (ASCT, day 0). The recommended dosage for palliative treatment is 16-mg/m2 administered as a single intravenous infusion over 15 to 20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals.^3,4

Renal Cell Carcinoma

On April 25, 2016, Cabometyx (cabozantinib) was approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior antiangiogenic therapy. Cabometyx was granted Fast Track and Breakthrough Therapy designations by the FDA.

Cabometyx is a kinase inhibitor that is available in a 20-mg, 40-mg, and 60-mg tablet. The recommended dosage for Cabometyx is 60-mg orally once daily with a full glass (at least 8 ounces) of water. Patients are advised not to consume grapefruits, grapefruit juice, or nutritional supplements that are known to inhibit cytochrome P450 while on this medication; and should not eat at least 2 hours before, and at least 1 hour after, taking Cabometyx. Cabometyx tablets are not to be substituted with cabozantinib capsules.^5,6

Urothelial Carcinoma and Non-Small Cell Lung Cancer

On May 18, 2016, Tecentriq (atezolizumab) was approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Furthermore, on October 18, 2016, Tecentriq was approved for the treatment of people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on an FDA-approved therapy for these aberrations prior to receiving Tecentriq. It is available in a 1200-mg/20 mL (60 mg/mL) solution in a single-dose vial. The recommended dose for Tecentriq is 1200-mg as an intravenous infusion over 60 minutes every 3 weeks. Medication should be diluted prior to intravenous infusion.^7,8,9

Soft Tissue Sarcoma

On October 19, 2016, Lartruvo (olaratumab) was granted accelerated approval in combination with doxorubicin for the treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate, and is not amenable to curative treatment with radiotherapy or surgery. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Lartruvo is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody. The recommended dose of Lartruvo is 15-mg/kg administered as an intravenous infusion over 60 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. For the first 8 cycles, Lartruvo is to be administered with doxorubicin. Lartruvo is available in a 500-mg/50mL (10-mg/mL) solution in a single dose vial.^10,11

Ovarian Cancer

On December 19, 2016, Rubraca (rucaparib) was approved as a monotherapy for the treatment of women with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies. Patients should be selected for therapy based on an FDA-approved companion diagnostic, such as FoundationFocus CDxBRCA.

This indication was granted accelerated approval based on objective response rate and duration of response. Rubraca is a poly (ADP-ribose) polymerase inhibitor that is available in a 200-mg and 300-mg tablet. The recommended dosage is 600-mg orally twice daily, with or without food. Treatment should be continued until disease progression or unacceptable toxicity. For adverse reactions, consider interruption of treatment or dose reduction.^12,13

Other Oncology and Oncology Support

On July 5, 2016, Syndros CX (dronabinol) was approved for the treatment of adults with anorexia associated with weight loss in patients with AIDS; and nausea and vomiting (N/V) associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Syndros is an orally active cannabinoid that has complex effects on the central nervous system, including central sympathomimetic activity. Syndros is available in a 5-mg/ml oral solution. For patients with anorexia associated with weight loss from AIDS, the recommended starting dosage is 2.1-mg orally, twice daily, 1 hour before lunch and dinner.

For patients with N/V associated with chemotherapy who have failed conventional antiemetics, the recommended starting dosage is 4.2-mg/m2, administered 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses per day.

The first dose should be given on an empty stomach at least 30 minutes prior to eating; subsequent doses can be taken without regard to meals. The calibrated oral dosing syringe included in the product packaging should always be used to measure the dose. Syndros should be taken with a full glass of water (6 to 8 ounces).^14,15

On August 10, 2016, Sustol extended-release injection, formerly APF530, was approved in combination with other antiemetics in adults 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. Sustol is a serotonin-3 (5-HT3) receptor antagonist available in an extended-release 10-mg/0.4ml single-dose, pre-filled syringe.

The recommended dosage in adults is 10-mg administered as a single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on day 1. Sustol should not be administered more frequently than once every 7 days, and use of Sustol with successive emetogenic chemotherapy cycles for more than 6 months is not recommended.^16,17

Additional Late-Breaking Specialty FDA Actions

On October 14, 2016, Lucentis (ranibizumab) received an expanded dosage form approval for 0.5-mg prefilled syringe (PFS) to treat people with wet age-related macular degeneration and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-vascular endothelial growth factor (VEGF) medicine approved to treat 2 eye conditions.

Lucentis is a VEGF inhibitor that was initially approved in June 2010 for the treatment of macular edema following RVO. It was approved in 2012 for the treatment of diabetic macular edema, and in 2015 for the treatment of diabetic retinopathy. Lucentis is available in 2 dosage strengths: 10-mg/mL (Lucentis 0.5-mg) and 6-mg/mL (Lucentis 0.3-mg) in single-use glass vials and 10-mg/mL PFS solution designed to provide 0.05-mL for intravitreal injection.^49,50

On November 4, 2016, Enbrel (etanercept) received an expanded indication for the treatment of pediatric patients (ages 4 to 17) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Enbrel is a tumor necrosis factor blocker that was initially approved in November 1998.

Enbrel is also indicated for the treatment of adult PsO, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, psoriatic arthritis, and ankylosing spondylitis. Enbrel is available in a 25-mg/0.5 mL single-dose prefilled syringe and in a 50-mg/mL solution in a single-dose prefilled syringe or in a single-dose prefilled SureClick Autoinjector. It is also available in a 25-mg lyophilized powder in a multiple-dose vial for reconstitution. The recommended dosage for pediatric PsO is 0.8-mg/kg weekly, with a maximum of 50-mg per week subcutaneously.^51,52

On November 4, 2016, Selzentry (maraviroc) received an expanded indication for the treatment of only CCR5-tropic HIV-1 infection, in patients age 2 years and older weighing at least 10 kg, in combination with other antiretroviral agents. Selzentry is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1. Selzentry is a CCR5 co-receptor antagonist that was initially approved in August 2007 for HIV in adults.

It is available in a 25-mg, 75-mg, 150-mg, and 300-mg tablet; and a 20-mg per mL oral solution. The recommended dose of Selzentry, in pediatric patients 2 years and older and weighing at least 10 kg, is based on body weight and concomitant medications and given twice daily, with or without food. Dosage should not exceed the recommended adult dose.^53,54

On November 10, 2016, Vemlidy (tenofovir alafenamide) was approved for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. Vemlidy is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor that comes with a boxed warning of lactic acidosis/severe hepatomegaly with steatosis and post treatment severe acute exacerbation of HBV.

Prior to initiation of Vemlidy, patients should be tested for HIV infection. Vemlidy alone should not be used in patients with HIV infection. Vemlidy is available in a 25-mg oral tablet, and the recommended dosage is 25-mg once daily with food.^55,56

On December 23, 2016, Spinraza (nusinersen) was approved for the treatment of spinal muscular atrophy in pediatric and adult patients. Spinraza is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide that is administered intrathecally. Spinraza received fast track designation, priority review and orphan drug designation by the FDA. Also, the sponsor is receiving a rare pediatric disease priority review voucher for prevention and treatment issued by the FDA.

The recommended dosage of Spinraza is 12-mg (5 mL) per administration. Initial treatment with Spinraza includes 4 loading doses; the first 3 loading doses should be administered at 14-day intervals; the 4th loading dose should be administered 30 days after the 3rd dose; a maintenance dose should be administered once every 4 months thereafter. Spinraza is supplied as a 12-mg/5 mL (2.4 mg/mL) solution in a single-dose, preservative-free glass vial.^57,58

On December 27, 2016, Adynovate (antihemophilic factor [recombinant] pegylated) received an expanded indication for hemophilia A (congenital factor VIII deficiency) treatment in pediatric patients under age 12 for on-demand treatment, control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes. Adynovate was also approved at that time for use in surgical settings for both adult and pediatric patients.

Adynovate was initially approved in November 2015 for the treatment of hemophilia A in adolescent and adult patients (12 years and older). Adynovate is not indicated for the treatment of von Willebrand disease. Adynovate is available as a lyophilized powder for reconstitution in single-use vials containing approximately 250, 500, 1000, or 2000 IU of factor VIII potency.

The dosage and duration of treatment depends on the severity of factor VIII deficiency, the location and extent of the bleed, and the patient’s clinical condition. Careful monitoring of replacement therapy is necessary in cases of serious or life-threatening bleeding episodes.^59,60

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48.

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49.

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57.

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58.

FDA approves first drug for spinal muscular atrophy, US FDA, December 23, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534611.htm Accessed: January 3, 2017.

59.

Adynovate Prescribing Information, Baxalta, December 2016. Available at: http://www.shirecontent.com/PI/PDFs/ADYNOVATE_USA_ENG.pdf Accessed: January 3, 2017.

60.

Shire Announces FDA Approval of Adynovate® [Antihemophilic Factor (Recombinant), PEGylated] for use in Children and Surgical Settings, Shire pic, December 27, 2016. Available at: http://www.prnewswire.com/news-releases/shire-announces-fda-approval-of-adynovate-antihemophilic-factor-recombinant-pegylated-for-use-in-children-and-surgical-settings-608390116.html Accessed: January 3, 2017.

About the Author

Stacey Ness, Pharm D, RPh, CSP, MSCS, AAHIVP, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence, and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, National Association of Specialty Pharmacy, Specialty Pharmacy Certification Board, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a certified multiple sclerosis specialist, a credentialed HIV pharmacist, a Certified Specialty Pharmacist, and currently serves as the senior director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, New Jersey.

Ruby Mhajan, RPh, currently serves as a clinical pharmacist at Managed Health Care Associates, Inc., a health care services organization based in Florham Park, New Jersey. Ruby has over 13 years of experience as a clinical pharmacist, having worked in both the United States and Canada in various settings including retail, long-term care, home infusion/specialty, and a national outsourcing admixture pharmacy. Most recently, she served as a Director of Pharmacy for a Home Infusion/Specialty Pharmacy in New York.