The only microtubule inhibitor approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

What's next...
what's possible.
Discover the possibilities for your mCRPC patients when prescribed JEVTANA early post docetaxel.
Prescribed to over 40,000 men*
*Estimate based on US sales & use data. 01/2010-10/2019
See Clinical Data, Including CARD Study Results
The efficacy and safety of JEVTANA were evaluated in the TROPIC and PROSELICA trials, which are included in the US Prescribing Information.
Most recently, results from the CARD study were published in the New England Journal of Medicine and presented at 2019 ESMO and 2020 ASCO GU.1,2
Click the tabs below to explore the trial results.

TROPIC Results

Validated JEVTANA as a treatment
in mCRPC after docetaxel1,3

PROSELICA Results

Established JEVTANA
20mg/m2 as the recommended dose
25mg/m2 can be used in select patients at HCP discretion.1

CARD Results

The first comparative,
prospective, phase 4 trial
evaluating JEVTANA versus
abiraterone or enzalutamide2-4

Validated JEVTANA as a treatment in mCRPC after docetaxel.1,3

Cabazitaxel (JEVTANA) is a National Comprehensive Cancer Network® (NCCN®) designated category 1 second-line therapy option for mCRPC patients who previously received docetaxel3

TROPIC trial (n=755): a randomized, open-label, international, multicenter study of JEVTANA (cabazitaxel) 25 mg/m2 (n=378) vs mitoxantrone 12 mg/m2 (n=377) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was overall survival (OS).1

TROPIC trial (n=755 ) JEVTANA (cabazitaxel ) vs mitoxantrone overall survival
  • JEVTANA significantly reduced risk of death by 30% vs mitoxantrone, an active comparator (95% CI: 0.59-0.83).
  • JEVTANA delivered a >30% reduction in tumors (RECIST criteria) in 3x more mCRPC patients vs mitoxantrone, an active comparator: 14.4% (29/201) (95% CI: 9.6-19.3) vs 4.4% (9/204) (95% CI: 1.6-7.2) (P=0.0005).
Safety of JEVTANA + prednisone (n=371) compared to mitoxantrone + prednisone (n=371)1
  • The most common (≥10%) grade 1-4 adverse reactions in patients who received JEVTANA vs mitoxantrone were anemia (98% vs 82%, respectively), leukopenia (96% vs 93%), neutropenia (94% vs 87%), thrombocytopenia (48% vs 43%), diarrhea (47% vs 11%), fatigue (37% vs 27%), nausea (34% vs 23%), vomiting (22% vs 10%), constipation (20% vs 15%), asthenia (20% vs 12%), abdominal pain (17% vs 6%), hematuria (17% vs 4%), back pain (16% vs 12%), anorexia (16% vs 11%), peripheral neuropathy (13% vs 3%), pyrexia (12% vs 6%), dyspnea (12% vs 4%), dysgeusia (11% vs 4%), cough (11% vs 6%), arthralgia (11% vs 8%), and alopecia (10% vs 5%)
  • The most common (≥5%) grade 3-4 adverse reactions in patients who received JEVTANA vs mitoxantrone were neutropenia (82% vs 58%), leukopenia (69% vs 42%), anemia (11% vs 5%), febrile neutropenia (7% vs 1%), diarrhea (6% vs <1%), fatigue (5% vs 3%), and asthenia (5% vs 2%)
NEXT: PROSELICA Study

Established JEVTANA 20mg/m2 as the recommended dose
25mg/m2 can be used in select patients at HCP discretion.1

PROSELICA trial (n=1,200): a non-inferiority, multicenter, randomized, open-label study of JEVTANA 20 mg/m2 (n=598) vs JEVTANA 25 mg/m2 (n=602) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was overall survival (OS).1

PROSELICA trial (n=1 ,200 ) 20 mg /m² JEVTANA (cabazitaxel ) vs 25 mg /m² overall survival
  • Per intent-to-treat population: 13.4 months (95% CI: 12.2-14.9) median OS for JEVTANA 20 mg/m2 and 14.5 months (95% CI: 13.5-15.3) for JEVTANA 25 mg/m2 (HR=1.024) (97.78% CI: 0.886-1.184).
  • No notable difference in OS was observed in subgroups based on the stratification factors, ECOG performance status score, measurability of disease, or region.
Incidence of Hematologic Laboratory Abnormalities with JEVTANA (cabazitaxel) 20 mg/m2 vs 25 mg/m2
Incidence of Adverse Reactions (ARs)* with JEVTANA 20 mg/m2 vs 25 mg/m2 in the PROSELICA Trial

*Grade from NCI CTCAE version 4.03. Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis. Based on adverse event reporting.§ Includes neutropenic sepsis.

  • 17% of patients on 20 mg/m2 and 20% of patients on 25 mg/m2 discontinued treatment due to ARs. The most common ARs leading to treatment discontinuation were fatigue and hematuria.
NEXT: CARD Study

The first comparative, prospective, phase 4 trial
evaluating JEVTANA versus abiraterone or enzalutamide2-4

CARD trial (n=255): a randomized, open-label, multicenter study in patients (n=255) with mCRPC who had previously received docetaxel and had disease progression within 12 months on an alternative androgen receptor-targeted agent (abiraterone or enzalutamide). The primary endpoint was imaging-based progression-free survival (rPFS) and secondary endpoints included overall survival (OS), tumor response, and safety.2

The CARD trial was an open label trial with no blinded central review of the standard imaging and was sponsored by Sanofi.3

The CARD trial was an open label trial with no blinded central review of the standard imaging and was sponsored by Sanofi.

*enzalutamide or abiraterone

ARTA=androgen receptor–targeted agent; BID=twice a day; DOCE=docetaxel; G-CSF=granulocyte-colony stimulating factor; Q3W=every 3 weeks; QD=once daily.
Median follow-up was 9.2 months from randomization until the end of the study.1
rPFS (radiographic progression-free survival) was defined as the time from randomization to the occurrence of one of the following events: radiological tumor progression using RECIST 1.1 (except for lymph nodes: if lymph node metastasis is the only evidence of metastasis at baseline, it must be ≥20 mm in diameter when measured by spiral CT or MRI (as defined by PCWG2)), progression of bone lesions according to PCWG2 criteria, or death.

KEY PATIENT ELIGIBILITY CRITERIA2

  • Histologically confirmed prostate cancer and castrate levels of testosterone (<0.5 ng/ml)
  • Prior treatment with docetaxel (at least 3 cycles; before or after AR-targeted agent)
  • Progression within 12 months with abiraterone or enzalutamide (before or after docetaxel)

Scroll down to see full patient baseline characteristics.

CARD Efficacy Overview
rPFS Was Significantly Improved With JEVTANA Compared With Abiraterone or Enzalutamide2
CARD Efficacy Overview: rPFS JEVTANA (cabazitaxel) compared with abiraterone or enzalutamide
  • All efficacy analyses were performed on the intention-to-treat population, at the cut-off date for 196 rPFS events.
  • After progression, the choice of subsequent anticancer treatment was at the discretion of the investigator. Of 126 patients randomized to an AR-targeted agent, 42 (33.3%) received JEVTANA after progression. Of 129 patients randomized to JEVTANA, 30 (23.3%) received abiraterone or enzalutamide after progression.
Overall Survival Was Significantly Improved With JEVTANA Compared With Abiraterone or Enzalutamide2
OS JEVTANA (cabazitaxel) compared with abiraterone or enzutamide
  • At the cutoff date, 153 deaths were noted, with 70 deaths (54.3%) occurring in the JEVTANA 25 mg/m2 group and 83 (65.9%) in the abiraterone or enzalutamide group.

The 25mg/m2 dose of JEVTANA was used in the CARD trial, which was conducted in Europe. The recommended starting dose of JEVTANA is 25mg/m2 in the European label.2

CARD Study Results added to the National Comprehensive Cancer Network (NCCN) Guidelines In Oncology (NCCN Guidelines®)3

Cabazitaxel at 25 mg/m2 with concurrent steroid improved radiographic PFS and reduced the risk of death compared with abiraterone or enzalutamide in patients with prior docetaxel treatment for mCRPC in the CARD study.

Tumor Response With JEVTANA Compared With Abiraterone or Enzalutamide4
Secondary Endpoint: Tumor Response (Patients With Measurable Disease at Baseline)
  • Partial response was measured by RECIST criteria, which is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
CARD Safety
No New Safety Signals Were Observed2
AE of Any Grade Reported in >=10% and/or Grade >=3 Reported in >=3% of Patients in Either Treatment Arm (Safety Population), No. (%)

*Musculoskeletal pain or discomfort included back pain, flank pain, musculoskeletal discomfort and pain, neck pain, or pain in extremities.
Renal disorder included acute kidney injury, renal failure and impairment, hydronephrosis, or pyelocaliectasis.
Spinal cord or nerve root disorder included sciatalgia, radiculopathy, or spinal cord compression.
§Psychiatric disorder included anxiety, depression, confusion, disorientation, or sleep disorder.

AEs Grade ≥3 Occurred at Similar Rates for Both Treatment Groups2
AEs Grade >=3 for both treatment groups

*Adverse events leading to death were assessed during the period from randomization to 30 days after the last treatment administration.
**Adverse events leading to death were assessed during the period from randomization to 30 days after the last treatment administration.

G-CSF was mandated every cycle per trial protocol. Per the full Prescribing Information, primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.2,3

Treatment Duration2
  • The median number of treatment cycles received was 7 cycles for patients on JEVTANA 25 mg/m2 compared with 4 cycles for those on abiraterone or enzalutamide. A treatment cycle was 3 weeks in both trial groups.
Dose Reductions2
  • At least 1 dose reduction occurred in 27 patients (21.4%) receiving JEVTANA 25 mg/m2 and in 47 patients (37.9%) receiving abiraterone or enzalutamide.
  • A dose reduction occurred in 17 of 58 patients (29%) receiving abiraterone and in 30 of 66 patients (45%) receiving enzalutamide.
Identify Appropriate Patients for JEVTANA in Your Practice
Overview of Patient Baseline Characteristics2,4
CARD Study: Ovierview of Patient Baseline Characteristics

§One patient (0.8%) had missing data in the JEVTANA group.

NEXT: Watch a video to see how JEVTANA works in the body

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
  • Severe hypersensitivity: Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

CONTRAINDICATIONS

JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500/mm3, patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80, and patients with severe hepatic impairment (total bilirubin >3x upper limit of normal (ULN)).

WARNINGS AND PRECAUTIONS

Bone Marrow Suppression (BMS): BMS manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed. Caution is recommended in patients with hemoglobin <10 g/dl.

Increased Toxicities in Elderly Patients: Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely.

Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to JEVTANA. Observe patients closely, especially during the first and second infusions. Discontinue JEVTANA immediately if severe hypersensitivity occurs and treat as indicated.

Gastrointestinal (GI) Adverse Reactions: Nausea, vomiting, and severe diarrhea may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials and mortality related to diarrhea has been reported. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing grade ≥3 diarrhea, dosage should be modified.

GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

Renal Failure: Cases, including those with fatal outcomes, have been reported. Identify cause and manage aggressively.

Urinary Disorders including Cystitis: Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

Respiratory Disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

Use in Patients with Hepatic Impairment: JEVTANA dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) and moderate (total bilirubin >1.5 to ≤3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administer JEVTANA 20 mg/m2 for mild hepatic impairment. Administer JEVTANA 15 mg/m2 for moderate hepatic impairment. Monitor closely.

Embryo-Fetal Toxicity: JEVTANA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of JEVTANA.

ADVERSE REACTIONS (ARs)

The most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 are neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia.

DRUG INTERACTIONS

Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk.
  • Lactation: The safety and efficacy of JEVTANA have not been established in females. There is no information available on the presence of JEVTANA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of JEVTANA.

Please see full prescribing information, including Boxed WARNING.


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