(Filing, 10-Q, Five Prime Therapeutics, NOV 5, 2015, View Source [SID:1234508018])

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(Filing, 10-Q, Tekmira Pharmaceuticals, NOV 5, 2015, View Source [SID:1234508064])

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On November 5, 2015 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) reported that new data from the ongoing dose-escalation and expansion studies of AG-221 and AG-120 in advanced hematologic malignancies will be presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, December 5-8, 2015 (Press release, Agios Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107405 [SID:1234507986]).

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In total, five abstracts led by Agios describing new clinical data from the company’s cancer metabolism and rare genetic metabolic disorders programs have been accepted for presentation at ASH (Free ASH Whitepaper), as well as two abstracts detailing new findings from the Natural History Study of pyruvate kinase (PK) deficiency being conducted with Boston Children’s Hospital. Agios’ IDH inhibitors AG-221 and AG-120 are being developed in collaboration with Celgene.

The accepted abstracts are listed below and are now available online on the ASH (Free ASH Whitepaper) conference website: View Source

Oral Presentation

Date & Time: Sunday, December 6, 2015 at 5:30 p.m. ET
Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Advances in Targeted Therapy
Abstract Number: 323
Presentation Title: Safety and Efficacy of AG-221, a Potent Inhibitor of Mutant IDH2 That Promotes Differentiation of Myeloid Cells in Patients with Advanced Hematologic Malignancies: Results of a Phase 1/2 Trial
Location: Orange County Convention Center, W110

Poster Presentations

Date & Time: Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. ET
Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Abstract Number: 1306
Presentation Title: Molecular Profiling and Relationship with Clinical Response in Patients with IDH1 Mutation-Positive Hematologic Malignancies Receiving AG-120, a First-in-Class Potent Inhibitor of Mutant IDH1, in Addition to Data from the Completed Dose Escalation Portion of the Phase 1 Study
Location: Orange County Convention Center, Hall A

Date & Time: Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. ET
Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Abstract Number: 1310
Presentation Title: Longitudinal Pharmacokinetic/Pharmacodynamic Profile of AG-120, a Potent Inhibitor of the IDH1 Mutant Protein, in a Phase 1 Study of IDH1-Mutant Advanced Hematologic Malignancies
Location: Orange County Convention Center, Hall A

Date & Time: Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. ET
Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Abstract Number: 2509
Presentation Title: Evaluation of the Pharmacokinetics of AG-221, a Potent Mutant IDH2 Inhibitor, in Patients with IDH2-Mutation Positive Advanced Hematologic Malignancies in a Phase 1/2 Trial
Location: Orange County Convention Center, Hall A

Date & Time: Sunday, December 6, 2015 from 6:00 p.m. to 8:00 p.m. ET
Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II
Abstract number: 2136
Presentation Title: The Phenotypic Spectrum of Pyruvate Kinase Deficiency (PKD) from the PKD Natural History Study (NHS): Description of Four Severity Groups By Anemia Status
Location: Orange County Convention Center, Hall A

Date & Time: Monday, December 7, 2015 from 6:00 p.m. to 8:00 p.m. ET
Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
Abstract Number: 3337
Presentation Title: Molecular Characterization of 140 Patients in the Pyruvate Kinase Deficiency (PKD) Natural History Study (NHS): Report of 20 New Variants
Location: Orange County Convention Center, Hall A

Date & Time: Monday, December 7, 2015 from 6:00 p.m. to 8:00 p.m. ET
Session Title: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
Abstract Number: 3336
Presentation Title: Population Pharmacokinetics and Pharmacodynamics of AG-348 in Healthy Human Volunteers Guide Dose Selection for the Treatment of Pyruvate Kinase Deficiency
Location: Orange County Convention Center, Hall A

On November 5, 2015 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies, reported that data from its ongoing clinical studies of LentiGlobin BB305 in beta-thalassemia major and severe sickle cell disease (SCD) will be highlighted in oral and poster presentations at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Filing, 8-K, bluebird bio, NOV 5, 2015, View Source [SID:1234508002]). The company will also present preclinical data from its lead oncology program, bb2121, in three posters at ASH (Free ASH Whitepaper). bluebird bio is developing bb2121 as an anti-BCMA oncology therapy in collaboration with Celgene Corporation. Preliminary data from all six of these abstracts will become available on the ASH (Free ASH Whitepaper) conference web site at 9:00 a.m. ET today.

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"Our expanding clinical experience with LentiGlobin continues to show promising clinical benefit in patients with beta-thalassemia major and severe sickle cell disease," said David Davidson, M.D., chief medical officer, bluebird bio. "We are pleased to see a median HbAT87Q level of 5.2 g/dL in the seven Northstar patients with beta-thalassemia major of all genotypes followed for six months or more, as this represents a substantial proportion of their total hemoglobin. It is exciting that transfusion independence has been achieved in all of our patients with beta‑thalassemia major with non-β0/β0 genotypes followed for at least six months in Northstar and HGB-205. Varying degrees of transfusion reduction have been observed in patients with β0/β0 genotypes. As would be expected, longer follow-up is required to assess the extent of HbAT87Q production and the impact on transfusion requirements in these patients with β0/β0 genotypes since they produce no functional beta-globin at baseline. Turning to sickle cell disease, our first treated patient is producing increased levels of HbAT87Q since we last reported on this study in June. HbAT87Q represented 48 percent of total hemoglobin at nine months post-infusion, and the patient remains transfusion independent without sickle cell-related adverse events as of the data cut-off. These results support the transformative potential of gene therapy, and we look forward to sharing more data at ASH (Free ASH Whitepaper)."

"The three accepted oncology abstracts represent the great progress we have made building our immuno-oncology business," said Rob Ross, M.D., head of oncology, bluebird bio. "These posters describe the encouraging pre-clinical data supporting the development of bb2121 in multiple myeloma, including our robust manufacturing platform, and key scientific insights into engineering more potent CARs that are applicable across our planned oncology portfolio."

LentiGlobin Presentations

Update of Results from the Northstar Study (HGB-204): A Phase 1/2 Study of Gene Therapy for Beta-Thalassemia Major via Transplantation of Autologous Hematopoietic Stem Cells Transduced Ex Vivo with a Lentiviral Beta AT87Q-Globin Vector (LentiGlobin BB305 Drug Product) (Abstract #201)

Presenter: Mark C. Walters, M.D., UCSF Benioff Children’s Hospital, Oakland, CA

Date: Sunday, December 6, 2015

Abstract Results, as of July 31st Data Cut-off:

· Seven subjects have been monitored for at least six months post-infusion: three of the β0/β0 genotype and four of the non-β0/β0 genotype.

· The median level of HbAT87Q expression among these seven subjects is 5.2 g/dL (range 1.9 to 8.2 g/dL), with total hemoglobin ranging from 8.5 to 11.1 g/dL at last visit.

· All four non-β0/β0 subjects have been transfusion-free for at least 90 days, with a median of 287 days transfusion-free (range: 171 to 396 days).

· Two of the β0/β0 subjects have received a single transfusion post-discharge, and one remains transfusion-dependent.

· All subjects engrafted.

· The safety profile was consistent with autologous transplantation. No Grade 3 or higher drug-product related adverse events have been observed, and there is no evidence of clonal dominance after a median follow-up of 198 days (range: 65 to 492 days).

Outcomes of Gene Therapy for Severe Sickle Disease and Beta-Thalassemia Major via Transplantation of Autologous Hematopoietic Stem Cells Transduced Ex Vivo with a Lentiviral Beta AT87Q-Globin Vector (Abstract #202)

Presenter: Marina Cavazzana, M.D., Ph.D., Hôpital Universitaire Necker – Enfants Malades, Paris, France

Date: Sunday, December 6, 2015

Abstract Results, as of July 31st Data Cut-Off:

· The subject with severe SCD is producing approximately 51.5% anti-sickling hemoglobin (48 percent HbAT87Q, 1.8 percent HbF, 1.7 percent HbA2) at nine months post-infusion.

· The subject with severe SCD remains free of transfusions.

· The subject with severe SCD has not had a post-treatment hospitalization for a disease-related event despite ceasing chronic transfusions on Day +88.

· Both subjects with beta-thalassemia major have remained transfusion-free for at least 15 months post‑infusion, with consistent expression of HbAT87Q – both subjects are β0/βE genotype.

· One additional subject with beta-thalassemia major had one month follow-up post-infusion.

· No subject has experienced a drug product-related adverse event, and there is no evidence of clonal dominance.

Initial Results from Study HGB-206: A Phase 1 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Severe Sickle Cell Disease (Abstract #3233)

Presenter: John F. Tisdale, M.D., National Institutes of Health, Bethesda, MD

Date: Sunday, December 6, 2015

Abstract Results, as of July 31st Data Cut-Off:

· LentiGlobin BB305 drug product has been manufactured for 2 subjects with severe SCD and 1 subject has been infused.

· The safety profile has been consistent with autologous transplantation, with no Grade 3 or higher drug product-related adverse events.

bb2121 Presentations

Manufacturing an Enhanced CAR T Cell Product by Inhibition of the PI3K/Akt Pathway During T Cell Expansion Results in Improved In Vivo Efficacy of Anti-BCMA CAR T Cells (Abstract #1893)

Presenter: Molly Perkins, D.Phil., bluebird bio, Cambridge, MA

Date: Saturday, December 5, 2015

Abstract Results, as of July 31st Data Cut-Off:

· In an in vivo aggressive lymphoma model, mice treated with anti-BCMA CAR T cells cultured with IL-2 and an inhibitor of PI3K experienced complete and long-term tumor regression; mice treated with anti-BCMA CAR T cells cultured only with IL-2 experienced no effect on tumor growth and succumbed to the tumors within two weeks after treatment; anti-BCMA CAR T cells grown in IL-7 and IL-15 also did not affect tumor growth.

· In an in vivo multiple myeloma model, mice received a single administration of anti-BCMA CAR T cells cultured under various conditions; all treatment groups demonstrated tumor regression regardless of culture conditions. In a model of tumor relapse, two weeks after tumor clearance, surviving mice were re-challenged with the same multiple myeloma model on the opposite flank; only animals that had been treated with anti-BCMA CAR T cells cultured with the PI3K inhibitor were able to resist subsequent tumor challenge.

· These data suggest that inhibition of PI3K during ex vivo expansion may generate a superior anti-BCMA CAR T cell product for clinical use; this approach could potentially be used in manufacture of other anti-tumor CAR therapies.

A Novel and Highly Potent CAR T Cell Drug Product for Treatment of BCMA-Expressing Hematological Malignancies (Abstract #3094)

Presenter: Alena Chekmasova, Ph.D., bluebird bio, Cambridge, MA

Date: Sunday, December 6, 2015

Abstract Results, as of July 31st Data Cut-Off:

· bluebird bio has developed a chimeric antigen receptor (CAR) targeting BCMA (bb2121) that consists of extracellular single chain variable fragment scFv antigen recognition domain derived from antibodies to BCMA linked to CD137 (4-1BB) co-stimulatory and CD3zeta chain signaling domains.

· Based on receptor density quantification bb2121 can recognize tumor cells expressing less than 800 BCMA molecules per cell.

· In a BCMA+ MM xenograph model, treatment with bb2121 resulted in rapid and sustained elimination of the tumors and 100 percent survival.

Characterization of Lentiviral Vector Derived Anti-BCMA CAR T Cells Reveals Key Parameters for Robust Manufacturing of Cell-Based Gene Therapies for Multiple Myeloma (Abstract #3243)

Presenter: Graham W.J. Lilley, M.Sc., bluebird bio, Cambridge, MA

Date: Sunday, December 6, 2015

Abstract Results, as of July 31st Data Cut-Off:

· Successful personalized medicine will require robust and reproducible cell manufacturing. A series of experiments were conducted to determine whether variations in anti-BCMA CAR surface expression resulted in changes in the activity of CAR T cells.

· The potency of the final drug product was shown to be independent of total anti-BCMA CAR expression on the cell surface.

· T cells transduced with varying MOIs to yield different amounts of CAR surface expression were diluted with donor-matched untransduced cells to achieve a uniform population of T cells containing 26 + 4 percent anti-BCMA CAR T cells. When exposed to tumor, these CAR T cell populations exhibited no difference in cytotoxicity against BCMA-expressing cells. All T cell productions easily achieved a level of anti-BCMA CAR expression that resulted in potent anti-BCMA activity.

· These data show that our manufacturing platform has been optimized to overcome significant challenges associated with personalized medicine by reducing the effects of variability while maintaining potency in autologous cellular drug product manufacturing.

On November 5, 2015 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 5-8 in Orlando (Press release, Genentech, NOV 5, 2015, View Source [SID:1234508022]). The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Genentech is exploring in various blood diseases and lines of treatment.

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"Our data at ASH (Free ASH Whitepaper) this year showcase the evolution of our hematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We’re particularly excited about studies evaluating new combinations with Gazyva and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity."

Data for Gazyva include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Genentech will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June this year.

Genentech will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Genentech will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, NHL, multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with hemophilia A with factor VIII inhibitors.

The table below contains key abstracts featuring Genentech medicines that will be presented. Follow Genentech on Twitter via @Genentech and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH2015.

Separately, the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for Gazyva in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal Phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Genentech and AbbVie announced positive top-line results from this study earlier this year.

Gazyva Indication

Gazyva is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

Important Safety Information

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that can become serious or life threatening, including:

Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If a patient has had history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen for hepatitis B before, and monitor the patient for hepatitis during and after, treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that may become severe or life threatening, including:

Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If a patient has a reaction, the infusion is either slowed or stopped until the patient’s symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is serious, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Signs of infusion reactions may include: dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, and chest pain.

Tumor Lysis Syndrome (TLS): Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. TLS, including death, has been reported in patients receiving Gazyva. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness.

Infections: While a patient is taking Gazyva, the patient may develop infections. Some of these infections may be severe. Fatal infections have been reported, so the patient should be sure to talk to the doctor if the patient thinks the patient has one. Patients with active infection should not be treated with Gazyva. Infections may continue even after the patient stops taking Gazyva. The patient’s doctor may prescribe medications to help prevent infections. Symptoms of infection include fever and cough.
Low White Blood Cell Count : When a patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s white blood cell counts. Neutropenia can develop during or after treatment with Gazyva. It may also last for more than one month. If a patient’s white blood cell count is low, the patient’s doctor may prescribe medication to help prevent infections.

Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in the blood. This may affect the clotting process. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s platelet count.
Most common side effects of Gazyva

The most common side effects of Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

Before receiving Gazyva, patients should talk to their doctor about:

Immunizations: Before receiving Gazyva therapy, the patient should tell the patient’s healthcare provider if the patient has recently received or is scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.

Pregnancy: A patient should tell the doctor if the patient is pregnant, plans to become pregnant, or is breastfeeding. Gazyva may harm the unborn baby. Mothers who have been exposed to Gazyva during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to the doctor about using Gazyva if the patient is breastfeeding.

Patients must tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.

Rituxan Indications

Rituxan (rituximab) is indicated for the treatment of patients with:

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy
Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
Rituxan is not recommended for use in patients with severe, active infections.

Important Safety Information:

Rituxan can cause serious side effects that can lead to death, including:

Infusion Reactions: may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before their treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart or chest pain.
Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or pustules.

Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving Rituxan could cause the virus to become an active infection again. Patient should not receive Rituxan if they have active HBV liver disease. The patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment.
Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body or blurred or lost vision.
What are the additional possible serious side effects of Rituxan?

Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:

Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm and can lead to death. The patient’s doctor may give the patient medicines before their treatment to help prevent TLS.
Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen or painful.
Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. The patient’s doctor may need to stop their treatment.
Kidney Problems: the patient’s doctor should do blood tests to check how well the patient’s kidneys are working.
Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom.
Low Blood Cell Counts: the patient’s blood cell counts may be monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness and low white blood cells.

Patients must tell their doctor if they are pregnant, plan to become pregnant or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.

Patients must tell their doctor about any side effect that bothers them or that does not go away.

These are not all of the possible side effects of Rituxan. For more information, patients should ask their doctor or pharmacist.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please see the Rituxan full Prescribing Information, including Most Serious Side Effects, for additional important safety information at View Source