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Volume 2 Published - 14:00 UTC    08:00 EST    24-February-2001      
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Back To Vidyya Product Approvals For Cancer Indications:

February 2001 Through June 1996 Listed By Approval Date


2001

 

  • Femara (letrozole) from Novartis Pharmaceuticals Company received additional approval on January 11, 2001 for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.(Approval Letter, Package Insert)

2000

  • Trisenox (arsenic trioxide) from Cell Therapeutics, Inc, received approval on september 25, 2000  for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.(Approval Letter, Package Insert)
  • Arimidex (anastrozole) from AstraZeneca Pharmaceuticals, received additional approval on September 1, 2000, for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.(Approval Letter)
  • Nolvadex (tamoxifen citrate) from AstraZeneca Pharmaceuticals, received additional approval on June 29,2000 for use in women with DCIS, following breast surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer.(Approval Letter, Package Insert)
  • Taxol (paclitaxel) from Bristol-Myers Squibb Company, received additional approval for the first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary.  As first-line therapy, Taxol, is indicated in combination with cisplatin. (Approval Letter, Package Insert)
  • Trelstar Depot (triptorelin pamoate) for injectable suspension, from Debio Recherche Pharmaceutique S.A., received approval on June 15, 2000 for the palliative treatment of advanced prostate cancer. (Approval Letter, Package Insert)
  • Fludeoxyglucose (F-18) injection from Downstate Clinical PET Center, received approval on June 2, 2000 as an (a) Assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found byother testing modalities, or in patients with an existing diagnosis of cancer. (b) Assessment of patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. (Approval Letter, Package Insert)
  • FocalSeal-L Surgical Sealant from Focal Inc., received approval on May 30, 2000 as a surgical sealant for use in lungs to seal air leaks following removal of cancerous lung tumors. (More Information)
  • Mylotarg (gemtuzumab ozogamicin) for injection, from Wyeth-Ayerst Research, recevied approval on May 17, 2000, for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. (More Information)
  • Camptosar (irinotecan hydrochloride) injection, from Pharmacia & Upjohn, received additional approval on April 20, 2000, as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.
  • Pacis (BCG,live), from BioChem Pharma Inc. received approval on March 9, 2000, for the treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the  bladder.
  • Viadur (leuprolide acetate implant), from Alza Corporation, received additional approval on March 3, 2000 for palliative treatment of advanced prostate cancer.  The drug product is delivered through a titanium device that is implanted in the upper arm, this is a new rout of administration for leuprolide acetate.

1999

Targretin (bexarotene) capsules, from Ligand Pharmaceuticals Inc., received approval on December 29, 1999 for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.

Taxotere (docetaxel), from Aventis Pharmaceuticals, received approval on December 23, 1999 for the treatment of non-small cell lung cancer that does not respond to cisplatin-based chemotherapy.

Celebrex (celecoxib), from G.D. Searle & Co., received accelerated approval on December 23, 1999 to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to unual care (e.g. endoscopic surveillance surgery). (Approval Letter, Approved Labeling)

Levulan Kerastick (aminolevulinic acid HCL) for Topical Solution, 20%, received approval on December 3, 1999 to be used in conjunction with photodyamic therapy for treatment of actinic keratoses (AKs) (pre-cancerous skin lesiions) of the face or scalp.  This is the first combined drug and device treatment designed for targeted treatment that can be limited just to the lesion site(s). Aminolevulinic acid HCL is marketed by DUSA Pharmaceuticals, Inc. of Valhalla, NY and will be marketed under the trade number Levulan Kerastick for Topical solution, 20%.  It is to be marketed in combination with the light source BLU-U Blue Light Photodynamic Therapy Illuminator. (Approval Letter, Labeling  )

Taxol (paclitaxel) injection, from Bristol-Myers Squibb, received additional approval on October 25, 1999 for adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing   combination chemotherapy.  In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow up 30 months) only in the patients with estrogen and progesterone receptor negative tumors.

Aromasin (exemestane) Tablets, from Pharmacia & Upjohn Company, received approval on October 21, 1999 for the treatment of advance breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Ellence (epirubicin hydrochloride), from Pharmacic & Upjohn received approval on September 15, 1999 for use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Zofran (ondansetron), from Glaxo Wellcome received additional approval on August 27, 1999  for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin.

Temodar  (temozolomide), from Schering-Plough Corporation received accelerated approval on August 11, 1999 for the treatment of adult patients with refractory anaplastic astrocytoma, (i.e. patients at first relapse who have experienced disease progression on a drug regimen containing a nitgrosourea and procarbazine).

Isolex 300 and 300i Magnetic Cell Selection System, Nexell Therapeutics, Inc., received approval on July 2, 1999, for processing autologous peripheral blood progenitor cell products to obtain a CD34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD34 negative tumors.

Kytril (granisetron), from SmithKline Beecham, received additional approval on June 27, 1999 for the prevention of nausea and vomiting associated with radiation, including total body irradiation (TBI) and fractionated abdominal radiation.

Doxil  (doxorubicin HCL liposome injection), from Alza Corporation, received accelerated approval on June 28, 1999 for a supplemental indication for the treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens.  Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment.( Labeling )

Ethyol (amifostine) for Injection, by US Bioscience, received additional approval on June 24, 1999 to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Ethyol is also marketed by Alza Pharmaceuticals. (Labeling)

DepoCyt (cytarabine liposomal injection, 10 mg/mL), by DepoTech Corporation, received accelerated approval on April 1, 1999 for the intrathecal treatment of lymphomatous meningitis.  This indication is based on demonstration of increased complete response rate compared to unencapsulated cytarabine.  There are no controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms, or increased time to disease progression, or increased survival. ( Labeling )

UVADEX (methoxsalen sterile solution, 20 mcg/mL), by Therakos, Inc. received approval on February 25, 1999 for the use of UVADEX with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.(Labeling)

Ontak ( denileukin diftitox ), marketed by Ligand Pharmaceuticals and manufactured by Seragen, Inc., received accelerated approval (based on tumor reduction) on February 5, 1999 for the treatment of persistent or recurrent cutaneous t-cell lymphoma, (CTCL), a rare slow-growing form of non-Hodgkin's lymphoma, whose malignant cells express the CD25 component of the IL-2 receptor.

Busulfex (busulfan), by Orphan Medical Inc received approval on February 4, 1999 for use in combination with cyclophosphamide as a conditioning regiment prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

Panretin (Alitretinoin) gel 0.1%, by Ligand Pharmaceuticals received approval on February 2, 1999 for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.  Approval Letter    Approved Labeling

Zofran ODT (odansetron) orally disintegrating tablets, by Glaxo Wellcome, Inc., received additional approval on January 27, 1999 for prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of postoperative nausea and vomiting (new dosage form).

1998

Photofrin (porfimer sodium), by QLT Phototherapeutics, Inc., received additional approval on December 22, 1998 for use in photodynamic therapy (PDT) for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobroncial nonsmall cell lung cancer (NSCLC).

Hycamtin (topotecan hydrochloride) for injection, by SmithKline Beecham Pharmaceuticals received additional approval on November 30, 1998 for the use of Hycamtin in the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.  In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy. (Labeling)

Sandostatin LARŪ Depot (octreotide acetate for injectable suspension), by Novartis Pharmaceuticals, was approved on November 25, 1998 for the reduction of growth hormone and IGF-1 in acromegaly, the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome and for the treatment of the profuse watery diarrhea associated with VIPoma (vasoactive intestinal peptide tumor). ( Labeling )

Actiq (fentanyl citrate), flavored sugar lozenge on a stick, by Anesta Corporation received approval on November 4, 1998 for management of chronic pain in cancer patients that are experiencing breakthrough pain on their regular narcotic (opioid) therapy. ( Patient Package Insert)

Nolvadex (tamoxifen citrate) by Zeneca Pharmaceuticals received additional approval on October 29, 1998 to reduce the incidence of breast cancer in women at high risk for breast cancer.

Camptosar (irinotecan hydrochlorise) by Pharmacia & Upjohn received additional approval on October 22, 1998 for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy.

Herceptin (trastuzumab) intravenous injection by Genentech, Inc., received approval on September 25, 1998 for use alone for certain patients who have tried chemotherapy with little success or as a first-line treatment for metastatic disease when used in combination with paclitaxel (trade name Taxol)(additional information)

Valstar (valrubicin) Sterile Solution for Intravesical Instillation, 5 mL, Single-Use Vials (40 mg/mL) by Anthra Pharmaceuticals received approval on September 25, 1998 for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

Gemzar (gemcitabine HCL) for injection by Eli Lilly & Co. received additional approval on August 26, 1998 for use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.

Zoladex, (goserelin acetate implant) by Zeneca Pharmaceuticals received additional approval on July 27, 1998 for use of 3.6 mg and 10.8 mg depots in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. [New dosage and Administration]

Ceprate SC Stem Cell Concentration System, from CellPro Incorporated received additional approval for processing peripheral blood progenitor cells to obtain a CD34 positive cell enriched population which is intended for hematopoietic support after myeloablative chemotherapy in patients with CD34 negative tumors.

Urowave Microwave Thermotherapy System by Dornier Medical Systems, Inc., received approval on May 29, 1998 as a non-surgical treatment alternative to transurethral resection of the prostate (TURP).  To treat symptomatic benign prostatic hyperplasia (BPH) in men withprostatic lengths between 30 mm and 55 mm.

Taxol (paclitaxel) injection by Bristol-Myers Squibb Pharmaceutical Research Institute received additional approval on June 30, 1998 for use in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

Taxotere (docetaxel) injection concentrate (20 mg and 80 mg) by Rhone-Poulenc Rorer received additional approval on June 22, 1998 for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

Xeloda (capecitabine) tablets by Hoffman-La Roche received accelerated approval on April 30, 1998 for treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.

Taxol (paclitaxel) injection by Bristol-Myers Squibb Pharmaceutical Research Institute received additional approval on April 9, 1998 for first-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.

Zoladex (goserelin acetate implant) by Zeneca Pharmaceuticals, Inc., received additional approval on April 9, 1998 for palliative treatment of advanced carcinoma of the prostate. [New Route of Administration]

Neupogen (filgrastim) by  Amgen, Inc. received additional approval on April 2, 1998 for use in patients with acute myeloid leukemia.

Daunorubicin HCL (daunorubicin hydrochloride) by Bedford Laboratories, Div. Ben Venue Laboratories, Inc., received approval on January 30, 1998, to provide a new 5 mg/mL, 4 mL ready-to-use solution which can be immediately used in an IV infusion without the possibility of reconstitution error.  Daunorubicin HCL's indication is for use in combination with other approved anticancer drugs for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

Proleukin (aldesleukin) sponsored by Chiron Corporation received an additional indication on January 9, 1998, for treatment of adults with metastatic melanoma and updated response data for metastatic renal cell carcinoma patients, as well as revised package insert information.

Photofrin (porfimer sodium) sponsored by QLT Phototherapeutics, Inc., received an additional indication on January 9, 1998, for treatment in photodynamic therapy for treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.

1997

Rituxan (rituximab) sponsored by Genentech, Inc., received approval on November 26, 1997, for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma.

Neumega (oprelvekin) sponsored by Genetics Institute, Inc., received approval on November 25, 1997, for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusion following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.

Intron A (interferon alfa-2a) sponsored by Schering Corp., received approval on November 6, 1997, for use in conjunction with chemotherapy in patients with follicular lymphoma.

Zofran (ondanstron hydrochloride) sponsored by Glaxo Wellcome Inc., received approval on October 31, 1997, for intramuscular administration as an alternative to intravenous administration in the prevention of postoperative nausea and vomiting (new route of administration.)

Anzemet (dolasetron mesylate Tablet) sponsored by Hoechst Marion Roussel, Inc., received approval on September 11, 1997, for the prevention of chemotherapy-induced nausea and vomiting, and prevention of postoperative nausea and vomiting.

Anzemet (dolasetron mesylate Injectable) sponsored by Hoechst Marion Roussel, Inc., received approval on September 11, 1997, for the prevention of chemotherapy-induced emesis, prevention of postoperative nausea and vomiting, and treatment of postoperative nausea and vomiting.

Taxol (paclitaxel) for Injection, sponsored by Bristol Myers Squibb Co. Pharmaceutical Research Institute, received an additional indication on August 4, 1997, for the second line treatment of AIDS-related Kaposis sarcoma. Taxol was previously indicated, after failure of first-line or subsequent chemotherapy for the treatment of metastatic carcinoma of the ovary, and for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Femara (letrozole) Tablets, sponsored by Novartis Pharmaceuticals Corporation, received approval on July 25, 1997, for the treatment of advanced breast cancer in postmenopausal women.

Lupron Depot (leuprolide acetate) for Injection, sponsored by TAP Holdings Incorporated, received an additional indication on May 30, 1997, to help relieve the symptoms associated with advanced prostate cancer. Lupron was previously indicated for management of endometriosis, preoperative hematologic improvement of anemia caused by uterine leiomyomata, palliative treatment of advanced prostate cancer and central precocious puberty.

Fareston (toremifene citrate) Tablets, sponsored by Orion Corporation, received approval on May 29, 1997, for the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor positive or receptor unknown tumors.

Quadramet (samarium sm 153 edtmp) for Injection, sponsored by Cytogen Corporation, received approval on March 28, 1997, for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

Zofran (ondansetron hydrochloride) Oral Solution, sponsored by Glaxo Wellcome Incorporated, received approval on January 24, 1997, for the prevention of chemotherapy, radiotherapy, and postoperative induced nausea and vomiting. Zofran was previously available in oral tablet and injectable formulations.

1996

Dostinex (cabergoline) Tablets, sponsored by Pharmacia & Upjohn Company, received approval on December 23, 1996, for the treatment of hyperprolactinemic disorders, either idiopathic (i.e. of unknown cause) or due to pituitary adenomas.

Novantrone (mitoxantrone hydrochloride) for Injection, sponsored by Immunex Corporation, received an additional indication on November 13, 1996, for use in combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone refractory prostate cancer. Novantrone was previously indicated for use in combination with other approved drugs in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.

Duraclon (clonidine hydrochloride) for Injection, sponsored by Fujisawa USA Incorporated, was approved on October 2, 1996, for continuous epidural administration (a type of injection) as additional therapy with intraspinal opiates (pain medication injected into the spinal column) for the treatment of severe pain in cancer patients that is not adequately relieved by opioid pain relievers alone.

Elliotts B Solution (calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate, dibasic) for Injection, sponsored by Orphan Medical Incorporated, was approved on September 27, 1996, for use in mixing methotrexate sodium and/or cytarabine for intrathecal administration (a type of injection) to prevent or treat meningeal leukemia or lymphocytic lymphoma.

Gliadel (carmustine wafer) for Implantation, sponsored by Guilford Pharmaceuticals Incorporated, was approved on September 23, 1996, for use in addition to surgery to prolong survival in patients with recurrent glioblastoma multiforme who qualify for surgery.

Nilandron (nilutamide) Tablets, sponsored by GH Besselaar Associates Incorporated, was approved on September 19, 1996, for use in combination with surgical castration for the treatment of stage D2 metastatic prostate cancer.

Aredia (pamidronate disodium) for Injection, sponsored by Ciba Geigy Corporation Pharmaceuticals Division, received an additional indication on July 16, 1996, for the treatment of osteolytic bone metastases of breast cancer. Aredia was previously indicated for hypercalcemia associated with malignancy, osteolytic bone lesions of multiple myeloma, and Paget's disease of bone.

Camptosar (irinotecan HCL) sponsored by Pharmacia and Upjohn, received accelerated approval on June 14, 1996, for treatment of metastatic carcinoma of the colon or rectum which has progressed or recurred after treatment with 5-fluorouracil (5FU).

Hycamtin (topotecan HCL), from SmithKline Beecham, received approval on May 28, 1996 for the treatment of metastatic ovarian cancer after failure of first line chemotherapy.

Zyloprim (allopurinol sodium) from Glaxo Wellcome, received approval on May 17, 1996 for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevation of uric acid levels and who cannot tolerate oral therapy.

Etopophos (etoposide phosphate) from Bristol-Myers Squibb, received approval on May 17, 1996 for the management of small cell lung cancer, firstline and refractory testicular tumors, in combination with other approved chemotherapeutic agents.

Gemzar ( gemcitabine HCL), from Lilly, received approval on May 16, 1996 for first line treatment for locally advanced (nonresectable stage II or III) or metastatic (stage IV) pancreatic cancer; second-line treatment for pancreatic cancer previously treated with 5-fluorouracil.

Taxotere (docetaxel) from Rhone-Poulenc Rorer, received approval on May 14, 1996 for the treatment of locally advanced or metastatic breast cancer which has progressed during anthracycline-based treatment or relapsed during anthracycline-based adjuvant therapy.

DaunoXome (daunorubicin citrate liposome) from NeXstar, received approval on April 8, 1996 for the first line cytotoxic treatment of advanced HIV-associated Kaposi's sarcoma.

Ethyol (amifostine), from Alza, received approval on March 15, 1996, for chemoprotectant/ cisplatin non-small cell lung cancer (NSCLC).

Blenoxane (bleomycin sulfate), from Bristol-Myers Squibb, received approval on February 20, 1996 as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.


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Editor: Susan K. Boyer, RN
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