Medication Monitor



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  • June 19, 2018

    Merck announced FDA approval of pembrolizumab to treat adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or relapsed PMBCL after two or more prior lines of therapy. With this indication, pembrolizumab becomes the first anti-PD-1 therapy to be approved for  treatment of PMBCL, a type of non-Hodgkin lymphoma. It is the second indication for the agent for treatment of a hematologic malignancy.

    This indication was approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. 

    The agent is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 

    Immune-mediated adverse reactions include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions and solid organ transplant rejection. Because of the severity of the adverse reaction, pembrolizumab should be withheld or discontinued and corticosteroids administered if appropriate. Immune-mediated complications, including fatal events, occurred in patients with classical Hodgkin lymphoma who underwent allogeneic hematopoietic stem cell transplantation after treatment with pembrolizumab.

  • June 15, 2018

    FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

    Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.

    At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their OUD cut their risk of death from all causes in half.

    One of the ways FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. Generic drugs approved by FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.

    Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema (accumulation of fluid causing swelling in lower limbs). These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

    Mylan Technologies and Dr. Reddy's Laboratories received approval to market buprenorphine and naloxone sublingual film in multiple strengths. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

  • June 14, 2018

    FDA approved bevacizumab for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for Stage III or IV disease after initial surgical resection.

    Approval was based on a multicenter, randomized, double-blind, placebo-controlled, three-arm study evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

    A total of 1,873 patients were randomized to carboplatin plus paclitaxel without bevacizumab, carboplatin plus paclitaxel with bevacizumab for up to six cycles, or carboplatin plus paclitaxel with bevacizumab for six cycles followed by single-agent bevacizumab for up to 16 additional doses. Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. On this trial, 1,215 patients received at least one bevacizumab dose.

    The primary efficacy outcome was investigator-assessed progression-free survival (PFS); overall survival (OS) was a secondary outcome. The estimated median PFS was 18.2 months for patients receiving bevacizumab with chemotherapy followed by single-agent bevacizumab (hazard ratio [HR] 0.62 [95% CI 0.52–0.75]; P < 0.0001). For those receiving bevacizumab with chemotherapy without single-agent bevacizumab, the estimated median PFS was 12.8 months (HR 0.83 [95% CI 0.70–0.98]; not significant).

    For patients receiving chemotherapy without bevacizumab, the estimated median PFS was 12.0 months. Estimated median OS was 43.8 months in the bevacizumab with chemotherapy followed by bevacizumab, compared with 40.6 months in the chemotherapy alone arm (HR 0.89 [95% CI 0.76–1.05]). 

    Adverse reactions occurring at higher incidence (at least 5%) of patients receiving bevacizumab were diarrhea, nausea, stomatitis, fatigue, arthralgia, muscular weakness, pain in extremity, dysarthria, headache, dyspnea, epistaxis, nasal mucosal disorder, and hypertension.

    Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms versus the control arm were fatigue, hypertension, decreased platelet count, and decreased white blood cell count.

    The recommended bevacizumab dose for Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to six cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.

  • June 14, 2018

    FDA granted accelerated approval of pembrolizumab to treat patients with cancer whose unresectable or metastatic solid tumors have a specific genetic feature (biomarker), referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

    This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

    MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial, and gastrointestinal cancers but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland, and other places. Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.

    Pembrolizumab works by targeting the PD-1/PD-L1 cellular pathway. By blocking this pathway, the drug may help the body’s immune system fight the cancer cells. FDA previously approved the agent to treat certain patients with metastatic melanoma, metastatic non–small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

    Safety and efficacy of pembrolizumab for this indication were studied in patients with MSI-H or dMMR solid tumors who were enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began. 

    A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials. The most common cancers were colorectal, endometrial, and other gastrointestinal cancers. Approval for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received pembrolizumab in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for 6 months or more.

    Common adverse effects  include fatigue, pruritus, diarrhea, decreased appetite, rash, fever, cough, difficulty breathing, musculoskeletal pain, constipation, and nausea.

    Pembrolizumab can cause serious conditions, known as immune-mediated adverse effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using pembrolizumab has occurred.

    Patients who experience severe or life-threatening infusion-related reactions should stop taking pembrolizumab. Women who are pregnant or breastfeeding should not take pembrolizumab because it may cause harm to a developing fetus or newborn baby.

    Safety and effectiveness of the agent in pediatric patients with MSI-H central nervous system cancers have not been established.

  • June 8, 2018

    Genentech announced FDA approval of rituximab to treat adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

    Rituximab is the first biologic therapy approved by FDA for PV and the first major advancement in treatment of the disease in more than 60 years. The agent is now approved to treat four autoimmune diseases.

    Approval was based on data from the Ritux 3 trial, a randomized, controlled trial conducted in France that used Roche-manufactured, European Union (EU)–approved rituximab product as the clinical trial material. The study compared the Ritux 3 regimen (EU-approved rituximab product plus short-term corticosteroids [CS]) to CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission at month 24 without use of steroids for 2 or more months.

    Results of the study showed that 90% of patients with PV treated with the Ritux 3 regimen met the endpoint, compared with 28% of patients with PV who were treated with CS alone. These results supported rituximab's efficacy in treating patients with moderate to severe PV, while tapering off CS therapy.

    Rituxan can cause serious adverse effects that can lead to death, including severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

    Common adverse effects include infusion reactions, infections (with fever and chills), body aches, tiredness, and nausea.

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