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WARNING
PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION
Melphalan, is a bifunctional alkylating drug that is active against selected human neoplastic diseases. Melphalan is available as melphalan hydrochloride salt. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. The molecular formula is C13H18Cl2N2O2.HCl and the molecular weight is 341.67.
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Melphalan is practically insoluble in water and has a pKa1 of ~2.5.
HEPZATO, for injection, is supplied as a sterile, nonpyrogenic, freeze-dried white to pale yellow freeze-dried cake/ powder. Each single dose vial contains melphalan 50 mg, equivalent to 56 mg of melphalan hydrochloride and 20 mg povidone.
HEPZATO (melphalan) is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and water for injection to a total of 10 mL.
HEPZATO (melphalan) for use with the hepatic delivery system is administered intra-arterially.
HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liverdirected treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
Sections or subsections omitted from the full prescribing information are not listed.
HEPZATO is a component of the HEPZATO KIT Hepatic Delivery System [HDS]. Refer to the HEPZATO KIT Hepatic Delivery System Instructions for Use (IFU) for additional instructions including pre-infusion evaluation, hydration, premedication, anticoagulation, and supportive care.
Caution: The double balloon catheter component of the HDS contains natural rubber latex which may cause allergic reactions [see CONTRAINDICATIONS].
Table 1: Calculation of IBW for HEPZATO Dosing
| Height | Ideal Body Weight | |
| Men | ≥ 152 cm | 52 kg + (0.75 kg/cm of height greater than 152 cm) |
| < 152 cm | 52 kg – (0.75 kg/cm of height less than 152 cm) | |
| Women | ≥ 152 cm | 49 kg + (0.67 kg/cm of height greater than 152 cm) |
| < 152 cm | 49 kg – (0.67 kg/cm of height less than 152 cm) |
A dosage reduction to 2 mg/kg is recommended for subsequent treatments for the following reasons:
HEPZATO administered with the HEPZATO KIT should be discontinued if patients have life threatening or HEPZATO-related persistent toxicity that has not resolved to Grade 2 or less by 8 weeks following treatment.
Refer to the HEPZATO KIT Hepatic Delivery System IFU for further details and instructions.
Reconstitute and dilute melphalan immediately prior to beginning intra-arterial infusion.
Reconstituted and diluted solutions of HEPZATO are unstable. No more than 60 minutes should elapse from reconstitution and completion of the intra-hepatic infusion of the diluted HEPZATO solution. A citrate derivative of melphalan has been detected in reconstituted HEPZATO in 30 minutes, and nearly 1% of labeled strength of melphalan hydrolyzes every 10 minutes when reconstituted HEPZATO is further diluted in 0.9% Sodium Chloride. A precipitate forms if the reconstituted solution is stored at 5°C. Do not refrigerate HEPZATO once reconstituted.
HEPZATO is a hazardous drug1. Follow applicable special handling and disposal procedures.
Reconstitution and Dilution Instructions:
HEPZATO (melphalan) is supplied in the HEPZATO KIT that contains the following:
The HEPZATO KIT includes the HEPZATO 5 x 5 Drug Pack and the Hepatic Delivery System (HDS). Each 5 x 5 HEPZATO KIT Drug Pack includes HEPZATO (melphalan) and diluents for reconstitution and dilution:
HEPZATO (melphalan) for injection must only be administered with the HDS device supplied with the HEPZATO KIT and components specified by Delcath Systems, Inc, in the IFU [see DOSAGE AND ADMINISTRATION].
HEPZATO for injection and its associated diluents including 0.9% sodium chloride must be stored at controlled room temperature 20°C to 25°C (68°F to 77°F). Temperature excursions are permitted between 15°C- 30°C (59°F-86°F) [see USP Controlled Room Temperature].
The Hepatic Delivery System components may be stored at room temperature.
Melphalan is a hazardous drug. Follow applicable special handling and disposal procedures.1
HEPZATO is light sensitive. Retain in original carton until use.
REFERENCES
1. OSHA Hazardous Drugs. OSHA. https://www.osha.gov/hazardous-drugs
Manufactured by: Mylan Institutional LLC, Made in Italy. Revised: Dec 2023.
Below are adverse reactions associated with HEPZATO KIT. Additional adverse reactions related to the procedure and/or medical device are described in further detail in the HEPZATO KIT IFU. The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug-device combination cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse drug reactions (ADRs) described in this section were identified from the FOCUS trial. FOCUS was a multicenter trial that evaluated HEPZATO (melphalan) administered via the HEPZATO KIT in patients with unresectable hepatic metastases from uveal melanoma. In the FOCUS trial, a total of 95 patients were enrolled into the HEPZATO KIT arm, of which 91 patients received treatment with HEPZATO.
Serious adverse reactions occurred in 45% of patients who received HEPZATO. Serious adverse reactions occurring in ≥ 2% of patients were thrombocytopenia (10%), neutropenia (8%), febrile neutropenia (7%), platelet count decreased (6%), leukopenia (4.2%), cardiac arrest (3.2%), neutrophil count decreased (2.1%), hypoxia (2.1%), pleural effusion (2.1%), pulmonary edema (2.1%), and deep vein thrombosis (2.1%). Fatal adverse reactions occurred in 3 (3.2%) patients who were treated with HEPZATO; these included cardiac arrest, acute hepatic failure and bacterial peritonitis.
HEPZATO was permanently discontinued due to adverse reactions in 18% of patients with neutropenia being the most common adverse reaction (3.2%) requiring permanent discontinuation.
Dose reductions due to an adverse reaction occurred in 14% of patients who received HEPZATO. Adverse reactions which required dose reductions occurring in ≥ 2% of patients were platelet count decreased (6%), neutropenia (4.2%), anemia (2.1%), and thrombocytopenia (2.1%).
Adverse reactions that required dosage interruption in ≥ 2% of patients who received HEPZATO were platelet count decreased (6%), neutropenia (5%), thrombocytopenia (3.2%), anemia (3.2%) and febrile neutropenia (2.1%).
The most common (≥20%) adverse reactions or laboratory abnormalities reported in patients treated with HEPZATO were thrombocytopenia (65%), fatigue (65%), anemia (63%), nausea (57%), musculoskeletal pain (46%), leukopenia (46%), abdominal pain (39%), neutropenia (35%), vomiting (35%), increased alanine aminotransferase (32%), prolonged activated partial thromboplastin time (28%), increased aspartate aminotransferase (28%), increased blood alkaline phosphatase (27%), and dyspnea (23%).
Table 2 and Table 3 summarize adverse reactions and laboratory abnormalities, respectively, that occurred in FOCUS.
Table 2 All Adverse Reactions Observed at a Frequency of >10% in Patients Treated with HEPZATO
| All Adverse Reactions N=95 | ||
| All Grades (%) | Grades 3 or 4 (%) | |
| Gastrointestinal disorders | ||
| Nausea | 57 | 0 |
| Abdominal Pain1 | 39 | 1 |
| Vomiting1 | 35 | 0 |
| Diarrhea1 | 17 | 1 |
| General disorders | ||
| Fatigue1 | 65 | 0 |
| Pyrexia1 | 16 | 0 |
| Musculoskeletal And Connective Tissue Disorders | ||
| Musculoskeletal Pain1 | 46 | 1 |
| Groin Pain | 11 | 0 |
| Respiratory disorders | ||
| Dyspnea1 | 23 | 2 |
| Cough1 | 15 | 0 |
| Nervous system disorders | ||
| Headache1 | 19 | 0 |
| Lethargy | 12 | 0 |
| Dizziness1 | 11 | 0 |
| Injury and procedural complications | ||
| Contusion | 17 | 0 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 16 | 0 |
| Vascular disorders | ||
| Hemorrhage1 | 15 | 1 |
| Hypotension1 | 13 | 3 |
| 1Represents a composite of multiple, related preferred terms | ||
Table 3: Laboratory Abnormalities Observed at a Frequency of >10% in Patients Treated with HEPZATO
| Laboratory Abnormality | All Laboratory Abnormalities N=95 | |
| All Grades (%) |
Grades 3 or 4 (%) |
|
| Platelets decreaseda | 65 | 55 |
| Hemoglobin decreaseda | 63 | 33 |
| Leukocytes decreaseda | 46 | 34 |
| Neutrophils decreaseda | 35 | 30 |
| Alanine aminotransferase increased | 32 | 3 |
| International normalized ratio increased | 31 | 8 |
| Activated partial thromboplastin time prolonged | 28 | 8 |
| Aspartate aminotransferase increase | 28 | 4 |
| Blood alkaline phosphatase increased | 27 | 2 |
| Calcium decreased | 13 | 3 |
| Troponin I increased | 13 | 2 |
| Blood bilirubin increased | 11 | 3 |
| a Represents a composite of multiple, related preferred terms | ||
No Information Provided
Included as part of the "PRECAUTIONS" Section
Hemorrhage, hepatocellular injury, and thromboembolic events have been observed when HEPZATO has been administered via hepatic intra-arterial administration. Administration of HEPZATO requires general anesthesia and extracorporeal bypass of circulation which may cause life threatening or fatal adverse effects. Ensure the patient is euvolemic but do not overhydrate the patient. Monitor for these peri-procedural complications during the procedure and for at least 72 hours following the procedure.
To mitigate the risk of thromboembolic events, administer anticoagulation as described in the IFU during the procedure.
Due to the risk of bleeding, do not use in patients with uncorrectable coagulopathies and delay treatment with the HEPZATO KIT for at least 4 weeks after surgery or other medical procedure involving the liver. Platelets and clotting factors may be removed during the HEPZATO KIT procedure. Monitor platelets and coagulation parameters as described in the IFU. If life-threatening bleeding occurs during the procedure, reverse anticoagulation as described in the IFU and correct coagulopathy as appropriate. Discontinue anticoagulation with warfarin or other oral anticoagulants prior to the procedure; resume when hemostasis has been restored after the procedure, provided no bleeding complications have been observed. Refer to the Prescribing Information of the anticoagulant agent for bridging recommendations for anti-coagulation prior to surgical procedures. Discontinue drugs affecting platelet function such as aspirin, nonsteroidal anti-inflammatory drugs, or other anti-platelet drugs one week before the procedure.
Patients with abnormal hepatic vascular (especially arterial supply) or biliary (especially re-implantation of bile duct) anatomy or gastric acid hypersecretion syndromes may be at increased risk of peri-procedural complications or other severe adverse reactions. Screen patients for a history of prior surgeries involving the bile duct to assess whether the patient is an appropriate candidate for HEPZATO KIT and monitor patients for adverse reactions following HEPZATO KIT administration.
Procedure-related reductions in blood pressure including severe hypotension can occur during the HEPZATO KIT procedure. Closely monitor blood pressure during the procedure. Patients may require fluid support and vasopressors. To reduce the risk of severe hypotension, assess hypothalamic-pituitary-adrenal axis function, and temporarily discontinue ACE-inhibitors, calcium channel blockers, or alpha-1-adrenergic blockers for at least 5 half-lives prior to treatment with the HEPZATO-KIT. If necessary, use other short-acting antihypertensive drugs to manage blood pressure during the peri-procedure period.
The HEPZATO KIT is only available through a restricted program under a REMS, because of the risk of severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events defined in the REMS. The HEPZATO KIT should only be used by trained healthcare providers [see Peri-Procedural Complications].
Important requirements of the HEPZATO KIT REMS include:
Further information is available at www.HEPZATOKITREMS.com or contact Delcath Systems at 1-833-632-0457.
Hematologic adverse reactions, including thrombocytopenia, anemia, and neutropenia have been reported in patients treated with HEPZATO. The risk of hematologic adverse reactions may be increased in patients who have received prior chemotherapy, bone irradiation, or who have compromised bone marrow function.
In the 95 patients who received HEPZATO in the FOCUS trial, 68% had Grade 3 or 4 myelosuppression. A total of 55%, 33%, and 30% experienced Grade 3 or 4 thrombocytopenia, anemia, and neutropenia, respectively. Median time to thrombocyte nadir was 13 days (range: 3-33) after treatment with median recovery in 20 days (range: 4-29) after treatment. Median time to hemoglobin nadir was 10 days (range: 3- 21) after treatment with median recovery in 13 days (range: 4-28) after treatment. Median time to neutrophil nadir was 11 days (range: 3-36) after treatment with median recovery in 17 days (range: 9-36) after treatment.
Monitor patients for severe infections, bleeding, and symptomatic anemia. Only administer HEPZATO in patients with platelets >100,000/microliter, hemoglobin ≥10.0 gm/dL and neutrophils >2,000/microliter. Administer transfusions or growth factors as appropriate [see DOSAGE AND ADMINISTRATION].
Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous (IV) formulation of melphalan. These reactions with melphalan are characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Hypersensitivity can occur in patients with or without prior exposure to IV or oral melphalan.
When a hypersensitivity reaction is observed, immediately terminate the hepatic arterial HEPZATO infusion and administer necessary supportive care [see CONTRAINDICATIONS].
Patients with a history of allergic reactions to iodinated contrast may experience hypersensitivity reactions, including anaphylaxis, during treatment with the HEPZATO KIT. Premedicate patients with a history of allergic reaction to iodinated contrast prior to treatment with HEPZATO KIT. Do not administer HEPZATO KIT in patients with a history of severe allergic reactions or anaphylaxis to iodinated contrast [see IFU, see CONTRAINDICATIONS].
Gastrointestinal adverse reactions including nausea and vomiting, abdominal pain, and diarrhea are common, and occurred in 84% of patients treated with HEPZATO in the FOCUS trial. Administer a proton pump inhibitor the day prior to and the morning of the procedure. If anti-emetic treatment is required, pre-medicate with anti-emetic therapy in subsequent cycles.
Melphalan has been shown to cause chromatid or chromosome damage in humans. Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patients with cancer treated with intravenous alkylating drugs including melphalan. Some patients also received other chemotherapeutic agents or radiation therapy. Precise quantification of the risk of acute leukemia, myeloproliferative syndrome, or carcinoma is not possible. Published reports of leukemia in patients who have received oral or IV melphalan (and other alkylating drugs) suggest that the risk of leukemogenesis increases with chronicity of treatment and with cumulative dose [see Nonclinical Toxicology].
Based on animal studies and its mechanism of action, melphalan can cause fetal harm when administered to a pregnant woman. Melphalan is genotoxic, targets actively dividing cells, and was embryolethal and teratogenic in rats. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with HEPZATO and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HEPZATO and for 3 months after the last dose [see Use In Specific Populations and Nonclinical Toxicology].
Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported [see Use In Specific Populations].
Adequate and well-controlled carcinogenicity studies have not been conducted in animals. However, intraperitoneal (IP) administration of melphalan in rats (5.4 to 10.8 mg/m2) and in mice (2.25 to 4.5 mg/m2) 3 times per week for 6 months followed by 12 months post-dose observation produced peritoneal sarcoma and lung tumors, respectively.
Intramuscular administration of melphalan at 6 and 60 mg/m2produced structural aberrations of the chromatid and chromosomes in bone marrow cells of Wistar rats.
Based on animal studies and its mechanism of action, melphalan can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see CLINICAL PHARMACOLOGY]. Melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see Nonclinical Toxicology]. In animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see Data]. Advise a pregnant woman of the potential risk to a fetus.
The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the United States general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Animal Data
Adequate animal studies have not been conducted with IV melphalan. Melphalan was embryolethal and teratogenic in rats following oral administration of 6 to 18 mg/m2/day for ten (10) days (0.05 to 0.16 times the recommended clinical dose of 3 mg/kg or 111 mg/m2/day) and intraperitoneal administration of 18 mg/m2(0.16 times the highest recommended clinical dose). Malformations resulting from melphalan administration included alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, and hepatocele (exomphaly).
It is not known whether melphalan is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing children from melphalan, breastfeeding is not recommended during treatment with melphalan and for one week after the last dose.
Melphalan can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating HEPZATO [see Pregnancy].
Females
Advise females of reproductive potential to use effective contraception during treatment with HEPZATO and for 6 months after the last dose.
Males
HEPZATO administration may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Advise males with female partners of reproductive potential to use effective contraception during treatment with HEPZATO and for 3 months after the last dose [see Nonclinical Toxicology].
Females
Melphalan causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients.
Males
Reversible and irreversible testicular suppression has been reported in male patients after administration of melphalan.
The safety and effectiveness in pediatric patients have not been established.
Clinical studies of HEPZATO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In the FOCUS trial, 30 of the 91 patients (33%) were 65 years and older.
No information on melphalan overdosage is available following administration of HEPZATO. Overdoses resulting in death have been reported following treatment with high intravenous (IV) doses of melphalan.
Overdoses via the IV route, including doses up to 290 mg/m2(approximately 7.5 mg/kg IBW), have produced the following symptoms: severe nausea and vomiting, decreased consciousness, convulsions, muscular paralysis, and cholinomimetic effects. Severe mucositis, stomatitis, colitis, diarrhea, and hemorrhage of the gastrointestinal tract occur at high IV doses (>100 mg/m2or approximately 2.6 mg/kg IBW). Elevations in liver enzymes and veno-occlusive disease occur infrequently. Significant hyponatremia caused by an associated inappropriate secretion of antidiuretic hormone syndrome has been observed. Nephrotoxicity and adult respiratory distress syndrome have been reported.
The principal toxic effect is bone marrow suppression. Hematologic parameters should be closely followed for three to six (6) weeks. General supportive measures together with appropriate blood transfusions and antibiotics should be instituted as deemed necessary by the physician. General supportive measures, together with appropriate blood and platelet transfusions, should be instituted if necessary and consideration given to hospitalization, antibiotic cover, and the use of hematological growth factors.
This drug is not removed from systemic plasma to any significant degree by hemodialysis or hemoperfusion.
HEPZATO and the HEPZATO KIT are contraindicated in patients with:
Melphalan is an alkylating drug of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. It is active against both resting and rapidly dividing tumor cells.
Melphalan exposure-response relationships and the time course of pharmacodynamic response following administration of HEPZATO via the Hepatic Delivery System are not fully characterized.
Geometric mean of systemic melphalan maximum concentration (Cmax) is 2.4 (%CV 3.0) mcg/mL and the AUC0-last was 1.8 (%CV 1.1) mcg*hr/mL.
The melphalan median (range) time to Cmax (Tmax) is 0.57 (0.05 – 1.18) hours following administration of HEPZATO.
The melphalan plasma protein binding is approximately 78% following administration of HEPZATO. Serum albumin accounts for approximately 40% to 60% and α -acid glycoprotein approximately 20% of the plasma protein binding.
The median terminal elimination phase half-life of 1.07 hours that is consistent with IV melphalan administration.
Metabolism
Melphalan is primarily metabolized by hydrolysis to inactive metabolites.
Excretion
Liver uptake and removal of melphalan by isolation of hepatic venous blood and subsequent filtration by HDS are the two main processes for reducing the amount of melphalan that is available systemically following administration of HEPZATO. HDS reduced systemic melphalan exposure with a mean (SD) filter efficiency of 82.7% (14.4%) for the total filtration period.
Systemic melphalan is eliminated by renal excretion of parent drug and metabolites.
No clinically significant differences in the pharmacokinetics of melphalan were observed based on body weight (43 - 150 kg), creatinine clearance (> 50 mL/min), or hepatic parameters (ALT (7 - 157 IU/L), AST (11 - 90 IU/L), or bilirubin (0.06 - 1.5 mg/dL) following administration of HEPZATO KIT.
The efficacy of HEPZATO in hepatic-dominant metastatic uveal melanoma was based on the results from 91 patients who received HEPZATO via the HEPZATO KIT in the FOCUS Study (NCT02678572), a multicenter, open-label trial. To be eligible for enrollment, patients were required to have metastatic uveal melanoma with metastases predominately involving the liver (liver dominant). Limited extrahepatic disease in the bone, subcutaneous sites, lymph nodes, or lung was permitted if the life-threatening component of the uveal melanoma was in the liver and the extrahepatic disease was amenable to resection or radiation and had a defined treatment plan. Patients with metastases in more ≥ 50% of the liver parenchyma, unable to undergo general anesthesia, ECOG ≥2, platelets < 100,000/microliter, absolute neutrophil count < 1,500/microliter, hemoglobin < 10 gm/dL, Child-Pugh Class B or C cirrhosis, or hepatitis B or C infection were excluded.
Patients received 3 mg/kg of melphalan based on ideal body weight (IBW, maximum total dose of 220 mg) administered intraarterially using the Hepatic Delivery System (HDS) every 6-8 weeks for up to 6 infusions. The median number of infusions administered per patient was 4 (range: 1-6). Thirty-seven percent (37%) of the 91 patients treated received the maximum of six infusions of treatment.
The major efficacy outcome measures were objective response rate (ORR) and duration of response (DoR) using computed tomography (CT) or magnetic resonance imaging (MRI) assessed by an independent central review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
The median age of patients was 61 years (range 20 to 78), 52% were female, 95% were White, 5% unavailable, and all patients had Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Ninety-five percent (95%) of enrolled patients had either 2 or 3 hepatic lesions. Seventy-nine percent (79%) of patients had <25% liver involvement. Thirty percent of the treated patients had extra-hepatic lesions, of which 20% had 1 extrahepatic lesion and 10% had 2 or more; overall 12% of patients had lung, 11% soft tissue/subcutaneous, 5% lymph node, and 4% had bone involvement. Fortythree percent (43%) of patients underwent prior therapy for metastatic disease, including systemic therapy (25%), other surgeries or procedures (14%), and radiation (11%).
The efficacy results of HEPZATO treatment are summarized in Table 4.
Table 4 Efficacy Results for Patients in FOCUS Trial
| HEPZATO (N=91) |
|
| Objective Response Rate | |
| ORR (95% CI)1 | 36.3% (26.4, 47.0) |
| Complete Response | 7.7% |
| Partial Response | 28.6% |
| Duration of response (months) | |
| Number of Responders | n= 33 |
| Median2 (months) (95% CI)3 | 14.0 (8.3, 17.7) |
| % Responder with DoR≥6 months4 | 70 % |
| % Responder with DoR≥12 months4 | 30 % |
| 1Clopper-Pearson method 2 Kaplan Meier method 3 Brookmeyer and Crowley method 4 Based on observed duration of response |
|
Advise patients or their caregivers of the following risks of the HEPZATO KIT:
