FDA grants Alecensa accelerated approval for people with a specific type of lung cancer

Roche announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumours in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53])

Possible serious side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids.

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumour response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

New clinical results from Gazyva/Gazyvaro

Roche announced updated data from the pivotal CLL11 study confirming that Gazyva®/Gazyvaro® (obinutuzumab) plus chlorambucil reduced the risk of disease worsening or death by more than half compared to MabThera®/Rituxan® (rituximab) plus chlorambucil (progression-free survival, PFS; HR=0.46, median PFS 28.7 months versus 15.7 months; p<0.0001). New results to be presented at the American Society of Hematology (ASH) Annual Meeting from a secondary endpoint that measured time to next treatment (TTNT) showed that, after completing the set six-month Gazyva/Gazyvaro regimen, people remained treatment-free for nearly four years on average before needing the next treatment for their cancer (TTNT; 51.1 months, including the six month initial treatment period). No unexpected safety signals were observed with Gazyva/Gazyvaro.

In the GREEN safety study, data from a subgroup analysis showed there were no unexpected safety signals when Gazyva/Gazyvaro was combined with bendamustine. In addition, nearly 80 percent of people responded to treatment with Gazyva/Gazyvaro plus bendamustine (overall response, ORR), and a third of people (32.3 percent) achieved a complete response (CR). A substantial number of people were also minimal residual disease (MRD) negative when measured in the bone marrow or blood (28 percent and 59 percent, respectively), which means no cancer can be detected using a specific test. Overall response rate and MRD were secondary endpoints of the study.

Roche and Upsher-Smith in Licence Agreement

Roche and Upsher-Smith Laboratories, Inc., through its wholly-owned UK subsidiary Proximagen Ltd., announced a worldwide agreement for the further development of a novel, oral small molecule inhibitor of Vascular Adhesion Protein 1 (VAP-1), a cell-adhesion molecule that may be effective in the treatment of inflammatory diseases. The VAP-1 inhibitor is currently in phase II clinical development.

Under the terms of the agreement, Roche is granted a worldwide exclusive license to develop and commercialize the compound. In a novel collaboration model, Roche and Proximagen will conduct additional phase II studies to further define the therapeutic potential of the VAP-1 inhibitor. Based on these data Roche will assume responsibility for late stage development and worldwide commercialization. Proximagen will receive an upfront payment, along with downstream development, regulatory and sales milestones. In addition, Proximagen will also receive tiered royalties on net sales of a potential future product containing the molecule.

Since 2012, Proximagen has been a wholly-owned subsidiary of Upsher-Smith. With an integrated drug discover facility based in Cambridge, UK, Proximagen acts as Upsher-Smith’s research and early development institute. Proximagen and its predecessor companies have a long heritage in discovery and development of novel small molecules, in particular in the areas of CNS, pain and inflammation.

FDA approves Cotellic in combination with Zelboraf

Roche announced that the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cotellic is Roche’s seventh new medicine approved by the FDA in the past five years.

Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity.

Cotellic and Zelboraf are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene. Found in approximately half of melanomas, mutated BRAF causes abnormal signaling inside certain cancer cells leading to tumor growth. Zelboraf is designed to inhibit some mutated forms of BRAF and Cotellic is designed to inhibit some forms of MEK. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth longer than with Zelboraf alone. A patient’s healthcare provider will perform a test to make sure Cotellic and Zelboraf are right for the patient. It is not known if Cotellic and Zelboraf are safe and effective in children under 18 years of age. 

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.,

Roche to present new clinical data across a variety of blood diseases

Roche announced that that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) Annual Meeting from December 5-8 in Orlando. The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Roche is exploring in various blood diseases and lines of treatment.

Data for Gazyva/Gazyvaro 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/Gazyvaro in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Roche will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva/Gazyvaro 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/Gazyvaro in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera/Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.

Roche 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, Roche will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, non-Hodgkin’s lymphoma (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 haemophilia A with factor VIII inhibitors.

FDA has accepted for priority review the company's supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro 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/Gazyvaro 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 6 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. Roche and AbbVie announced positive top-line results from this study earlier this year.

Roche expands cobas 4800 System menu

Roche announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.

The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory.

The assays launched today will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System.

CHMP recommends EU approval for combination of Cotellic and Zelboraf

Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cotellic (cobimetinib), when used in combination with Zelboraf® (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Approximately 50% of melanoma skin cancers are BRAF-positive, and more than 55,000 people worldwide die every year from melanoma.

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. A V600 mutation of the BRAF protein occurs in approximately half of melanomas, and should therefore be tested to identify the best treatment option. When melanoma is diagnosed early, it is generally a curable disease but most people with advanced melanoma have a poor prognosis. More than 232,000 people worldwide are currently diagnosed with melanoma each year. In recent years, there have been significant advances in treatment for metastatic melanoma, and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.

Zelboraf was the first approved treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test, such as Roche’s cobas 4800 BRAF Mutation Test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma. Cotellic (cobimetinib) is designed to selectively block the activity of MEK, one of a series of proteins inside cells that make up the MAPK signaling pathway that helps regulate cell division and survival.

Cotellic is also being investigated in combination with several investigational medicines, including immunotherapy, in several tumour types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.

Roche receives FDA CLIA waiver for flu A/B test

Roche announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B test for use on the cobas® Liat System. It is the first CLIA-waived, real-time polymerase chain reaction (PCR) test to detect influenza A and B in ~20 minutes. Coupled with the CLIA waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.

An estimated three to five million individuals develop influenza each year worldwide, and 250,000 to 500,000 die from the virus. Patients at highest risk include children, the elderly and pregnant women. The CLIA waived cobas Influenza A/B test for the cobas Liat PCR System offers an effective, new diagnostic tool to clinicians for the upcoming flu season and provides faster diagnosis and treatment for patients in primary and urgent care settings.

The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver, following the cobas Strep A test, which received CLIA waiver in May 2015. The cobas Liat Analyzer, cobas Influenza A/B test and cobas Strep A test are CE Marked, FDA cleared and CLIA waived.