Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
• Mantle Cell Lymphoma
Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
• Acute Lymphoblastic Leukemia
Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Metastatic Colorectal Cancer (mCRC)
• Bevacizumab in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC).
• Bevacizumab in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
• Bevacizumab in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
Recurrent Glioblastoma (GBM)
• Bevacizumab is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma (mRCC)
• Bevacizumab in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
• Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Bevacizumab in combination with carboplatin and paclitaxel, followed by Acura® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
• Bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
• Bevacizumab in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Acura® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Hepatocellular Carcinoma (HCC)
• Bevacizumab in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Crohn’s disease
Guselkumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Ulcerative colitis
Guselkumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
• Mantle Cell Lymphoma
Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
• Acute Lymphoblastic Leukemia
Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Metastatic Colorectal Cancer (mCRC)
• Bevacizumab in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC).
• Bevacizumab in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
• Bevacizumab in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
Recurrent Glioblastoma (GBM)
• Bevacizumab is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma (mRCC)
• Bevacizumab in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
• Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Bevacizumab in combination with carboplatin and paclitaxel, followed by Acura® as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
• Bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
• Bevacizumab in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Acura® as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Hepatocellular Carcinoma (HCC)
• Bevacizumab in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Elacestrant Dihydrochloride monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least line of endocrine therapy including a CDK 4/6 inhibitor for at least 12 months.
This indication is approved based on progression free survival. Continued approval of this indication may be contingent upon verification and description of clinical benefit (overall survival) in the confirmatory trials.
Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men 18 to 64 years.
Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria:
• An intravaginal ejaculatory latency time (IELT) of less than two minutes.
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes.
• Marked personal distress or interpersonal difficulty as a consequence of PE.
• Poor control over ejaculation.
• A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Dapoxetine Hydrochloride should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Malignant pleural mesothelioma
Pemetrexed Disodium in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Disodium in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Pemetrexed Disodium is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Pemetrexed Disodium is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Registration
Generic Drug
MenQuadfi
Meningococcal (Serogroup A) Polysaccharide 10 ug, Meningococcal (Serogroup C) Polysaccharide 10 ug, Meningococcal (Serogroup Y) Polysaccharide 10 ug, Meningococcal (Serogroup W135) Polysaccharide 10 ug
Meningococcal (Serogroup A) Polysaccharide 10 ug, Meningococcal (Serogroup C) Polysaccharide 10 ug, Meningococcal (Serogroup Y) Polysaccharide 10 ug, Meningococcal (Serogroup W135) Polysaccharide 10 ug
SFDA Approved Use
MenQuadfi is indicated for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.
