StreetInsider.com News Articles

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration has accepted a supplemental Biologics License Application for Lunsumio VELO (mosunetuzumab-axgb), a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin-piiq) to treat adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy. The FDA is expected to make a decision by February 9, 2027.

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA accepts Genentech's application for Lunsumio and Polivy combo

Thu, 18 Jun 2026 01:00:23 -0400

The application is based on data from the Phase III SUNMO study. At a median follow-up of 23.2 months, the combination showed a 59%

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

Thu, 18 Jun 2026 01:00:00 -0400

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today

Chartwell Law Selects Aderant Expert Sierra to Drive Cloud Transformation, Supporting Firmwide Growth

Wed, 17 Jun 2026 09:01:00 -0400

Expert Sierra empowers Chartwell Law to scale seamlessly, accelerate profitability, and gain real-time visibility across operations

ATLANTA--(BUSINESS WIRE)-- Aderant, a leading global provider of business management solutions for law firms has announced that Chartwell Law, a NLJ 500 law firm with nearly 300 attorneys, has adopted Aderant Expert Sierra, the innovative cloud-based practice and financial management platform. The move positions Chartwell Law as a cloud-first law firm, gaining scalability, security, and centralized visibility to support its rapid growth nationwide.

Expert Sierra will enable Chartwell Law to